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

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 various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas
• Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality
• Engineers, R&D, and Regulatory Affairs
• Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation
• Assist the Team Lead/Manager in the development of schedules to ensure timely delivery
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
• Train and mentor junior members of the team on technical/process related aspects
• Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities
• Perform literature searches on various databases
• Screening, appraisal per pre-defined criteria, and summarization of articles
• Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use
• Summarize quantitative data from post-marketing surveillance
• Conduct editing, proofreading, document formatting, and other document completion/approval activities

Education

• Bachelor’s Degree / Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred.

Experience

• Publication experience in scientific journals preferable
• Minimum 3 years of experience in Medical Device Regulatory documentation
• Familiarity with the Life Sciences Industry, preferably Regulatory Services
• Hands on experience on CEP/CER/PMSR/PSUR process
• Experience in creating high quality deliverables for customers
• Experience in handling projects and engaging with multiple clients independently
• Experience of working on projects involving all devices classes from various Therapeutic Areas

Technical/Functional Skills

• Knowledge of clinical evaluation and related documents and regulatory requirements
• Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature
• Proficiency with Microsoft Office (Word, Excel, and Outlook)
• Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage
• Effective reviewing skills for review of work done by trainees/junior writers

Non-Technical Skills

• Strong verbal and written communications skills
• Ability to work as part of a team
• A constant zeal towards learning and skill development
• Potential to multitask and work within timelines
• Ability to understand and deliver on customer requirements
• Mentoring skills to act as trainer/mentor for junior members of the team

Personal Traits

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

Competencies

• Basic English grammar, punctuation, and sentence construction
• Logical comprehension
• Knowledge of medical terminology
• Excellent Communication (Writing and Verbal)
• Quality focused mindset
• Good time management
• Good stakeholder management

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

• The Director Regulatory Data Management is responsible for delivering high quality services and projects to Celegence customers for data management.
• The position leads a team specialized in the submission and reporting of data (primarily) describing Medicinal- and pharmaceutical products, Organizations and Substances.
• Focus is on ensuring the highest possible data quality and compliance with existing guidance, regulations, and data standards.
• The position closely cooperates with the Regulatory Affairs (RA) department of Celegence customers and contributes to the correct use and implementation of data to support their business processes.
• Typical activities include providing consultancy and other support related to process development, data cleansing and remediation activities, vendor selection and system implementation.
• The position coordinates daily operations, project and resource planning for the Data Management group and establishes and maintains an excellent working
  relationship with Celegence customers.
• The position can also be involved in the development of the in-house developed and maintained solutions (such as Dossplorer™, Dosscriber ™ and Hosted platform). This position on a need basis function as a Subject Matter Expert, where the responsibilities are ensuring translating business needs to functional requirements and supporting Software Development activities.
• This position will support pre-sales and marketing initiatives related to regulatory data management function.
• The position will act as line manager for individual team members and acts as a coach on achieving goals and developing necessary skills of all team members within the department.

Key Responsibilities & Tasks

1. Coach Team Members
   • Coach on achieving goals and develop skills of individual team members.
   • Resolve conflicts
2. Team Planning and Organization
   • Identify team goals, resource planning and prioritizes work activities
   • Organization of team roles and responsibilities
   • Volunteers to assist team with overflow duties
3. Project and Services Delivery
   • Ensure high quality projects and services are delivered to Data Management customers.
   • Consults with team members to ensure targets and deliverables are met.
   • Provides consultancy on data management related aspects in business process development and implementation
4. Vendor Selection and System Implementation
   • Evaluate and validate software supporting regulatory information management.
   • Leading role in implementing regulatory information management solutions and vendor selection.
   • Leading/ supporting data migration and remediation tasks
5. Quality Management System
   • Responsible for the Data Management related processes and procedural documents.
   • Participates in the development, maintenance and improvement of procedural documents and templates to support the activities mentioned above.
6. Track Regulatory Documents, Publications, and Other Related Materials
   • Proactively consulting and checking information sources for new, changed, and updated materials. For example: new regulatory guidance or data standards
7. Data Management
   • Monitor data quality and initiate mitigating and corrective activities to improve data quality.
   • Ensure compliance with guidelines and regulations.
   • Ensure and promote correct use of data.
   • Ensure timely and valid submission of electronic data submissions
8. Solution Development Support
   • Support technical solutions for regulatory data management as SME.
   • Implement tech enabled services by adopting technology solutions to increase efficiency, quality and consistency.

Formal Education

• Higher professional education (or combination of education and working experience to an equal level), preferred in Life Sciences.

Experience

• Expert knowledge of Regulatory Affairs, in particular regulatory information management, with at least 10+ years of adequate professional experience
• Knowledge and experience of the drug development process, regulatory filing guidelines and electronic submissions
• Experience with data management tools and platforms relevant to the life sciences industry
• Experience with software development is a plus.

Qualifications: General Soft Skills

• Affinity with Information Technology and automation
• Strong Leadership abilities
• Good organizational skills, including efficiency and collaboration in a team environment.
• Proficiency with computer skills, including MS Office and Adobe Acrobat
• Ability to manage and deliver through others in a matrix environment.
• Ability to work within a demanding environment with a strong focus on quality and timelines.
• A passion for data quality and a commitment to continuous improvement.
• Eager to learn an array of technical tools.
• High analytical skills
• Flexible, able to adapt to emerging situations.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good knowledge of English (spoken and written)
• Quality focused by transparent systematic and consistent approach.
• Ability to work concurrently on multiple projects, each with specific features that may differ from project to project.

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.