At Celegence, you have the opportunity to shine and truly make a difference.

We have a growing organization where your inputs will be valued.

We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds.

Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment.

Celegence is an Equal Employment Opportunity Employer.

All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment.

Please read Celegence’s Privacy Policy for more information on how we process your data during the Recruiting and Hiring process.

Project Delivery Management - Celegence Life Sciences

Project Delivery Management

MDR Regulatory and Consultancy - Celegence Life Sciences

Regulatory Affairs Data Management

Compliance Data Management - Celegence Life Sciences

Compliance Data Management

Regulatory Intelligence - Celegence Life Sciences Regulations

Regulatory Intelligence

Why Celegence?

Join us and be a part of a remarkable journey!

Here at Celegence, you get a great team that always stands by you, a supportive Manager who makes sure you are absolutely comfortable with the work you’re doing, an amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then), and most importantly, here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.

Employee Testimonials

Sowmya Raju - Celegence - Testimonial

Celegence is one of the most promising young companies in the industry. After more than two years working here, I can confidently say that it provides great opportunities to anyone in the organization looking to enhance their knowledge and skills. The culture has allowed me to grow my leadership and management skills, and it has also been motivating to have been part of the company’s growth since early on. Working at Celegence, a ‘typical day’ is never typical, there is always an interesting new challenge to navigate and every day is filled with learning opportunities. The company allows us to wear many hats, which keeps the workplace exciting and fast paced.

The aspect of Celegence that I have enjoyed most is the support system from Senior Management. They are open to new ideas and they always provide assistance for any obstacles that my team might be facing. I thoroughly enjoy working in such a collaborative atmosphere and am truly grateful to be a part of this organization.

Sowmya Raju, Senior Regulatory SME
Jegathis Kumar - Celegence Life Sciences
I am happy to be a part of the Celegence family. It has been a great learning experience from Celegence so far and the friendly environment here helps me work enthusiastically every single day. Because of the teamwork and the support from the team members I was able to achieve “The Employee of Choice Award” in a short period of time. Definitely looking forward to learning more and growing along with Celegence’s family.

Jegathis Kumar, Junior Associate, Regulatory Affairs
Koushik Chakraborty - Junior Associate Regulatory Affairs – Celegence

I started my professional career with Celegence. Right from the day of virtual on-boarding as a fresher in pandemic, till date, I feel Celegence is my [extended] family. With a positive work culture, teamwork, transparency, colleague support, and motivation from my seniors, I tend to grow each day. We celebrate each festival together. With work, we also focus on fun activities that relax us from our daily schedule. Celegence is growing every single day and so am I with Celegence. I recommend joining Celegence for people who really want to follow their passion and to get an amazing work experience. Thankful and obliged to Celegence for providing me with an excellent opportunity to excel in my career.This is my journey with Celegence!
What’s yours?

Koushik Chakraborty, Junior Associate, Regulatory Affairs
Koushik Chakraborty - Junior Associate Regulatory Affairs – Celegence

I have been working at Celegence for over a year. I have had the opportunity to work on challenging and complex projects in varied therapeutic areas that have further improved my skills as a medical writer. I am grateful to be working with a talented, diverse and supportive team that I can count on. I like that Celegence recognizes and appreciates the work and contribution the employees make towards the team and the organization. I am proud to be a part of Celegence that is making an impact in the healthcare sector via regulatory compliance.

Dr. Anushree Singh, Medical Writer
Akanksha Dhasmana - Instructional Designer - Celegence

I’m glad to gain experience in Celegence. This company allows you to wear multiple hats, empowers you with freedom to make decisions and has a great mix of all age groups to collaborate and create an inspiring work environment. I have a lot to be thankful to my Manager as they are behind this great learning experience. Right from my interview with my Manager and then later with the HR, I knew that Celegence is going to have a great enhancement in my learning. Not only is it a blessing to work with the team members and managers here, but it also gives me challenges that help me to hone my work and efforts. Also, I’m grateful to all my colleagues here who contributed to my journey so far. I’m definitely keen to cover many more years of this amazing learning.

Akanksha Dhasmana, Instructional Designer
Akanksha Dhasmana - Instructional Designer - Celegence

Celegence is a great place to work. The culture is transparent, every employee, irrespective of their position is given a chance to be heard, and there are very good opportunities available to those who want to build a career here.
It is a young organization with an innovative and entrepreneurial approach that distinguishes it from its competitors. I have been with the organization for almost 3 years now and have seen myself transform as a professional in more than one way. In the meantime, I have gained valuable experience on most of the interesting digital marketing activities to which I have been assigned. I have the utmost respect for the company’s drive to continuously develop new technologies and improve working process and employee skills. I work very closely with our COO which has given me a valuable insight into a different culture and great level of learning.

Santhosh Kumar, Senior Digital Marketing Analyst

Current Job Openings at Celegence

Senior Associate II – Publishing & Submission

Job Location: Bangalore, India

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Member of the P&S and RIMS Centre of Excellence team responsible for the Lifecycle Management of assigned products.
  • Document level Publishing: Author and Publish the technical, regulatory documents based on the client’s product requirements.
  • Submission Level Publishing: Compiles the dossier in the required format for submission to the relevant agencies.
  • Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions.
  • Manage various activities under product life cycle management (Registration, Variation, Renewals, and submission)
  • Prioritize target activities and produce high-quality deliverables.
  • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables.
  • Adherence to appropriate regulatory guidelines, departmental SOPs, and Client SOPs for the deliverables.
  • Complete training provided by the Client, and regular self-trainings; archive training certificates/records.
  • Flexible to work in shifts.
  • Assist and support internal audits performed by the Client.
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects.
  • Understands and will abide by ISMS policy and processes of the company.

Education

  • Master’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields.
  • Japanese language reading and writing ability is a must.
  • RAC certification is a plus.

Experience

  • Minimum 3-5 years of relevant Regulatory publishing and submission and Regulatory Information Management Systems experience required.
  • Understanding of global regulations related to Pharmaceuticals, Medical Devices, and Biologics in the context of service offerings.
  • Experience in creating customer-facing materials.
  • Able to work independently.
  • Fluent in English and Japanese.
  • Chinese – Mandarin language preferred.

Technical/Functional Skills

  • Hands-on experience related to Regulatory Processes, including related IT systems, including Document Level Publishing and Submission Level Publishing
  • Regulatory Information Management Systems (RIMS)

Personal Traits

  • Positive Attitude
  • Initiative and Commitment
  • Detail Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Competencies

  • Good Communication (Writing and Verbal)
  • Customer focused
  • Drive to deliver superior quality proposals
  • Strong time management
  • Proactive and solution orientation

Soft Skills

  • Possess strong verbal and written communication skill
  • Strategic thinking
  • Ability to influence others
  • Problem-solving skills

HR & Office Coordinator

Employment Type: Full Time, On-Site

Job Location: Waalwijk, Netherlands

About the Company

Our company is a rapidly growing innovator in the healthcare sector, committed to transforming the healthcare landscape through cutting-edge solutions. Celegence Provides Services and Solutions to Support the Life Sciences Industry with Regulatory Affairs Operations and Strategy. We are dedicated to improving patient outcomes through intelligent regulatory compliance. We support companies in ensuring their regulatory compliance across the globe by providing trained resources, knowledge, and technology to assist our clients in their day-to-day operations.

Roles & Responsibilities

Recruitment & Onboarding

  • Support in local recruitment process (posting vacancies on relevant portals, first-screening, scheduling interviews)
  • Support with new joiner onboarding (e.g. hand-out of office keys, laptop preparation, etc.)
  • Completing mandatory documents for personnel files
  • Registering colleagues with insurers, pensions and HR systems.
  • Initiating onboarding with relevant departments (access, rights, functional orientation etc.)

Off-Boarding & Exit Management

  • Support the off-boarding processes (e.g. return of equipment).
  • Confirming terminations of employment
  • Deregistering colleagues from insurers and pensions
  • Initiating offboarding at involved departments (access, rights, etc.)

Office Administration

  • Greeting visitors and providing general administrative support to our employees
  • Meeting facilitation (e.g. taking notes during general)
  • Coordinating & Organizing social events at site
  • Oversee maintenance of office and equipment. (e.g. contact with cleaning company, office supply, waste management, printer maintenance)
  • Support with administrative activities in the DM, RA, P&S
  • Full assistance with conference registration, hotel booking, visa requests, etc.

HR Support

  • Answering colleagues and managers regarding salaries, vacation days, contract changes, sick reports, parental leave, and more
  • Daily management of the HR mailbox, including processing HR changes and absence registrations
  • Assisting with projects such as subsidy applications, updating the employee handbook, improving employment conditions
  • Providing support for absenteeism prevention, vitality, employee satisfaction surveys and automation of repetitive tasks.
  • Identifying opportunities for improvement in HR processes and making improvement proposals

Qualifications

  • Completed HBO education
  • Have around 3-5 years of experience in an administrative HR role
  • Up-to-date knowledge of employment law and the Gatekeeper Act
  • Strong and proactive with independent decision-making skills
  • Accurate and service-oriented with a passion for results-oriented work
  • Experience with NMBRS and MS Office is a plus

Benefits

We offer a competitive compensation package, comprehensive benefits, and a supportive work environment that fosters professional growth and development. Join our team and be part of an organization that is making a real difference in the lives of patients worldwide.

To Apply

Please submit your resume and a cover letter highlighting your relevant experience and qualifications. We are an equal opportunity employer and value diversity in our workforce.

IVDR – Subject Matter Expert

Employment Type: Full Time

Job Location: Bangalore, Office based

Celegence is looking for an In Vitro Diagnostic Regulation (IVDR) – SME with 4+ years of work experience (full time) in an In-Vitro Diagnostic medical device related industry.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Ensure on-time development and delivery of high-quality regulatory documents (Technical files, GSPRs, Gap Assessments, Risk management documentation, etc.) compliant with IVDR
  • Collaborate with Program Managers and other departments to determine action items and deliverables to address gaps in quality system(s) and product files
  • Assist with program management of deliverables per project plan, if needed
  • Assist with the creation/revision of IVDR procedures, forms and templates
  • Initiate and route change orders to implement procedures at toxicology sites
  • Assist with the implementation of new tech file template at toxicology sites
  • Review and approve deliverables for technical files, such as verification and validation testing protocols and reports, post marketing surveillance reports, risk
  • Write technical files per IVDR requirements and route for review and approval
  • Correspond with Notified Bodies to obtain certifications
  • Correspond with EU Authorized Representative for product registrations and EUDAMED updates
  • Track and report status of regulatory affairs deliverables to management
  • Other tasks may be assigned of a regulatory affairs nature, as needed
  • Ad-hoc support with marketing activities, such as webinars, blog writing, as well as business development activities such as presales meetings with prospective clients
  • Actively participate in client bid defence meetings for IVD / Medical Device prospective projects
  • Provide advisory consulting services, proactively monitor regulations across regions to advise companies on new regulations
  • Provide SME consulting in the areas of regulatory strategy, submissions, and operations
  • Support building (technical) documentation and design dossiers in support of CE marking, 510(k), or other approval procedures
  • Conduct Technical File reviews specific for products being authorized
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business
  • Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager
  • If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements
  • Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards
    • Lead IVDR gap analysis projects and conduct an analysis of existing systems, processes, and departments in terms of new regulation
    • Implement improvements to technical files and other PMS documents like Performance Evaluation Plan (PEP), Performance Evaluation reports (PER), Analytical Performance Report (APR), Scientific Validity Report (SVR), and Clinical Performance Report (CPR).
    • Understand current compliance situation of the medical device for international standards
    • Suggest and support the implementation of changes to the organization’s risk management processes
    • Develop device risk assessments with input from clinical and technical experts within the organizations
    • Identify actions required to ensure compliance with ISO 13485, MDSAP and IVDR
    • Support and conduct updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-IVDR
    • Make updates to labelling, SOPs, work instructions, and policy documents to ensure compliance with the client’s corporate SOPs
  • Assist in the development/construction of Technical Files according to the new IVDR & STED format with emphasis on developing following documentations:
    • Essential Requirements Evaluation Report to Annex I of MDR & IVDR
    • Risk Management Reports / Documentation to ISO 14971:2012
    • PMPF Planning Report development according to IVDR and/or MEDDEV
    • Development of Vigilance Reporting strategies to IVDR and/or MEDDEV
  • Maintain, develop, and share your expertise and knowledge on a specific expert area and participate in IVDR-related forums to understand the latest trends as well as approach prospective clients
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Establish and maintain a professional and credible relationship with direct clients (customers of Celegence) and indirect clients like Health Authorities, Notified Bodies, and other regulatory agencies.
  • Responsible for the operational planning of the project and preparing weekly plans for the team which are in line with the project timelines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines, and documents as required
  • Proactively follow the news and trends in the market to share with the rest of the team
  • Supporting internal and external audits as required
  • Provide status reporting to stakeholders according to an agreed communications plan

Education & Experience

Education:

  • PhD in a relevant area for in-vitro diagnostic medical devices can substitute 3 years of work experience provided it includes 2 years’ experience in design, manufacture or testing
  • RAC certification: Medical Devices or In Vitro Diagnostics is a plus

Experience:

  • In addition to a relevant educational degree, candidates must have a minimum 4 years’ work experience (full time) in an In-Vitro diagnostic medical device related industry, academia or hospital environment, with at least 2 of these years in the design, manufacturing, testing or use of the device in which they are qualified to Audit / Assess, and/or experience as an assessor in a notified body (five full technical documentation assessments)
  • A proven track record for driving quality/compliance improvements across all levels and functions
  • Experience in IVDR remediation projects, writing IVDR compliant reports and documents
  • Knowledge of Quality Management System and ISO 13485
  • Regulatory Affairs compliance and QMS assessment of Technical Files
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Experience in creating customer facing materials and conducting workshops as SME
  • Knowledge of Invitro Diagnostics and Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada

Skills

Technical Skills

  • Excellent knowledge of IVDD/IVDR
  • Excellent knowledge of ISO 13485 standards
  • Good understanding of IMDRF requirements for member countries
  • Strong stakeholder management experience

Soft Skills

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Good knowledge of strategy development and implementation techniques for Medical Device registrations, compliance towards new regulations, etc.
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance
  • Flexibility to work on other PMS documentation complying with the IVDR

Medical Writing – Pharma – SME

Employment Type: Full Time

Celegence is looking for a Medical Writing SME with over 13 years of experience in Regulatory Affairs related to Labelling across EU and the US Markets.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL, USA, with offices in the UK, EU, and India. We provide customers consulting services and solutions to support their regulatory affairs operations and strategy. Our fully trained resources support companies in their day-to-day operations by ensuring global regulatory compliance, leveraging their expert knowledge, and our technology and automation to improve compliance.

The vision of Celegence is to be the premier niche provider of regulatory services and solutions, to improve outcomes for the life sciences industry. Our primary objective is to provide end-to-end regulatory solutions enabling life science organizations to deliver exceptional patient value.

Roles & Responsibilities

    • Responsible as the Subject Matter Expert (SME) for project activities, coordination with offshore team and representatives from different departments at customer, as well as hands-on document preparation using the relevant tool in coordination with the Project Manager.
    • Understand different source documents and reports like company core data sheet, SmPC, US labels, HA assessment reports, previous finalized reports etc.
    • Ensure setting up end to end processes for CCDS management related to Customer’s product lifecycle activities.
    • Perform label reviews.
    • Supports gap analysis activities, preparation of draft CCDS, Health authority website check and other activities which are performed as a part of CCDS creation and update
    • Understand report template requirements and existing reports for updates as part of the project activities.
    • Provides guidance for literature search and literature review.
    • Author and review the Clinical Overview, Non-Clinical Overview, and medical evaluation document.
    • Performs review of the Draft CCDS.
    • Provides general regulatory guidance.
    • Undergo training by customer for their specific processes (e.g; SOP), systems for data extraction, quality review procedures etc.

Education & Experience

Education:

    • A first degree or higher education in life sciences

Experience:

    • Over 13 years of experience within the pharmaceutical industry

Skills

Technical Skills

    • Experience in Regulatory Affairs related to Labelling across EU and the US Markets

Soft Skills

    • Fluent in written and verbal English
    • Proficient with computer skills, including MS Office applications

Competencies

    • Knowledge of RA regulations in the field of Global labelling management activities
    • Creation and maintenance of Company Core Data Sheets (CCDS), Summary of Product Characteristics (SmPC), Patient information leaflet (PIL/PI)
    • Ability to multitask under tight deadlines while providing attention to detail and high-quality work in a dynamic environment
    • Scientific knowledge sufficient to understand all aspects of regulatory issues

Personal Traits

    • Good planner
    • Well organised
    • Strong team player
    • Customer focused
    • Skilled communicator
    • Ability to work independently

Regulatory Affairs – SME

Employment Type: Full Time

Celegence is looking for a Regulatory Affairs SME with 5 – 7 years of relevant experience.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
  • Manage various activities in RIMS database under product life cycle management (Registration, Variation, Renewals and submission)
  • Prioritize target activities and Produce high quality deliverables
  • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables
  • Adherence to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Assist and support internal audits performed by Client
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects
  • Support peers and resolve issues related to project
  • Develop and establish standard processes in collaboration with QA submission related checklists and template preparation (wherever applicable)
  • Conduct quality control of performed regulatory work as part of the daily routine
  • Set-up and maintain local SOP system describing all procedures and processes to ensure compliance and share with Client
  • Effective usage of applicable RA electronic systems
  • Accountable for resource utilization, management and competency development of the teams assigned with inclusion at Individual level role
  • Understands and will abide by IQMS policy and processes of the company
  • Lead/Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
  • Ensure customer success throughout the engagement
  • Drive end to end IDMP data preparation & readiness: data assessment at source, data remediation, data transformation, data enrichment and data completeness

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification is a plus

Experience:

  • Minimum 5 – 7 years of relevant Regulatory Affairs experience required
  • Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide and SPOR
  • With good understanding of regulatory information management & associated business processes, provides expertise in managing IDMP data & processes in a global RIMS platform
  • Skilled in Regulatory Information Management
  • Business processes experience and good understanding of RIMS processes, Publishing, Labeling, CMC and Other Variations, Manufacturing and supply chain etc.
  • Performed SME role in the past for implementation projects and regulatory affairs business process areas and training delivery experience is a plus
  • Familiar with current knowledge of electronic document and submission requirements applicable to the EU, US, and global regulatory environments
  • Participated in the implementation of new health authority guidelines and rules relevant to regulatory submissions
  • Experience coordinating with artwork supply, artwork review and approval of artwork for labelling variations
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Working experience or understanding of external pharmaceutical data standards like pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.
  • Knowledge of regulations, legislation, best practices and guidelines relating to RIMS or compliance initiatives. (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards etc.)
  • Experience in customer interaction and ensure customer success throughout the engagement
  • Able to work independently

Skills

Technical Skills

  • Hands on experience related to Regulatory Processes including related IT systems
  • Hands of experience on presentation tools like PowerPoint, Visio etc.

Non-Technical Skills

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Worked in the capacity of lead or senior role responsible for project or sub workstream in the past

Competencies

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management

Personal Traits

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Bookkeeper/Accounting Assistant – Chicago, IL

Employment Type: Full Time

Celegence is looking for a Bookkeeper/Accounting Assistant in Chicago, IL region with 5 or more years of bookkeeping and accounting experience.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Reconcile the company’s bank statements and bookkeeping ledgers
  • Prepare invoices for customers and manage payments collection process
  • Keep track of upcoming monthly/quarterly/annually invoices for customers
  • Receive and record bills and prepare report of upcoming payments
  • Maintain and promote excellent vendor relations
  • Complete analysis of employee expenditures
  • Manage income and expenditure accounts
  • Generate the company’s financial reports using income and expenditure data
  • Monitor the company’s finances based on financial status
  • Document transaction details
  • Generate financial reports
  • Fact-check accounting data
  • Notify senior staff of any accounting errors
  • Record financial transactions
  • Prepare semi-monthly payroll and track payroll data
  • Manage customer contracts and SOW timeframes, issue timely invoices, and review collection payments

Education & Experience

Education:

  • Bachelor’s degree or higher in Finance & Accounting, or equivalent work experience
  • QuickBooks Online Certification, preferred

Experience:

  • 5 or more years of bookkeeping and accounting experience

Skills

Technical Skills

  • In depth knowledge and experience with QuickBooks Online (QBO)
  • Initiate and manage financial/accounting software used by the company, QBO and Excel required
  • Accounts Receivable, Accounts Payable, G/L, Billing, Invoice Management, Payroll, etc.

Non-Technical Skills

  • Strong knowledge of all Microsoft Office applications
  • Excellent data entry skills, preferred
  • Customer service skills

Competencies

  • Strong written and verbal communication skills
  • Ability to communicate complex data in a clear way
  • Problem solving and complex thinking skills
  • Ability to meet deadlines
  • Works well under pressure and responds well to tight deadlines
  • Ability to work in a team and on your own
  • Experience using time management skills such as prioritizing, organizing, and tracking to manage meeting deadlines and multiple projects with varying completion dates
  • Accomplish goals with little or no supervision, depending on self to complete objectives and determine when escalation of issues is necessary

Personal Traits

  • Works with integrity and ethically
  • Upholds organizational values
  • Sincere, focused, and detail oriented
  • Positive Attitude
  • Ability to manage, motivate, and inspire people to embrace change

Medical Device Regulatory Consultant – Europe, UK, USA

Roles & Responsibilities

  • Maintain, develop, and share your expertise and knowledge on a specific expert area and participate in MDR related forums to understand the latest trends as well as approach prospective clients
  • Actively participate in client bid defense meetings for Medical Device prospective projects
  • Provide advisory consulting services, proactively monitor regulations across regions to advise companies on new regulations
  • Provide SME consulting in the areas of regulatory strategy, submissions and operations
  • As a medical device expert, you will support to build (technical) documentation and design dossiers in support of CE marking, 510(k), or other approval procedures
  • Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e. MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA, ANVISA, Heath Canada, MHLW/PMDA & TGA (MDSAP requirements)
  • Lead MDR gap analysis projects and conduct analysis of existing systems, processes and departments in terms of new regulation.
  • For MDR Gap Assessments you will perform the following: Work with stakeholders to identify required changes to compliance processes and updating associated process documentation including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas
    • Implement improvements to technical files and other documents like Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER)
    • Understand current compliance situation of medical device to international standards
    • Suggest and support implementation of changes to organization’s risk management processes
    • Develop device risk assessments with input from clinical and technical experts within the organizations
    • Identify actions required to ensure compliance with ISO 13485, MDSAP and MDR
    • Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-MDR
    • Make updates to labelling, SOPs, work instructions and policy documents to ensure compliance with the client’s corporate SOPs
  • Assist in the development/construction of Technical Files according to the new MDR & STED format with emphasis on developing following documentations:
    • Essential Requirements Evaluation Report to Annex I of MDR & IVDR
    • Risk Management Reports / Documentation to ISO 14971:2012
    • Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV 2.7.1 Rev 4
    • PMCF Planning Report development according to MDR & IVDR and/or MEDDEV
    • Development of Vigilance Reporting strategies to MDR & IVDR and/or MEDDEV
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Establish and maintain a professional and credible relationship with direct clients (customer of Celegence) and indirect clients like Health Authorities, Notified Bodies and other regulatory agencies
  • Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project time lines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required
  • Proactively follow the news and trends in the market to share with the rest of the team
  • You may be asked to support marketing activities, such as webinars, blog writing, as well as business development activities such as presales meetings with prospective clients
  • Supporting internal and external audits as required
  • Provide status reporting to stakeholders according to an agreed communications plan

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification: Medical Devices is a plus

Experience:

  • Minimum 5 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality or regulatory roles
  • Experience writing MDR compliant Clinical Evaluation Reports and other documents
  • Knowledge of Quality Management Systems implementation to ISO 13485:2016
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Experience in creating customer facing materials and conducting workshops as SME
  • Knowledge of Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada
  • Worked in a client-focused organization as a consultant in the past
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Excellent knowledge of MDD/MDR
  • Excellent knowledge of ISO 13485 standards
  • Good understanding of IMDRF requirements for member countries
  • Strong stakeholder management experience

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Good knowledge of strategy development and implementation techniques for Medical Device registrations, compliance towards new regulations etc.
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance
Life Sciences Regulation - Celegence Careers

Competitive Compensation & Benefits

Celegence Growth Company - Life Sciences Regulations

Supportive Work Environment

Celegence Careers - Life Sciences Regulations

Growth Opportunities

Join Our Team

​If you are interested in joining our team, please fill out the form below or email careers@celegence.com and we will contact you for further discussion.

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