Medical Devices Registration Manager – India

Celegence is looking for a Medical Device expert to oversee and deliver a project to support our client with registering multiple medical device products in several countries.

Roles & Responsibilities

  • Familiarize with pharmaceutical and medical device products related regulations, requirements and guidelines. Also, be responsible for the implementation and compliance of the regulatory requirements
  • Manage product registration in line with company strategy to ensure compliance with local regulatory requirement and company requirements
  • Ensuring ongoing compliance and maintenance of product registration to meet regulatory and business obligations
  • Work closely with local regulatory authorities to ensure a high level of current knowledge is maintained regarding product registration and maintenance of product within the market segments the business aims to conduct its business
  • Ensuring promotion materials and communication to HCPs, customers and end users are reviewed in line with the company and industrial Codes of Conduct. Apply advertisement permit when required
  • Manage the reporting and management of Pharmacovigilance activities for Medical Devices in India, Sri Lanka and Bangladesh in accordance with the company SOPs and local regulatory requirements
  • Support local quality activities by working closely with cross functions and external organization like:
    • Local Commercial, Supply Chain team
    • Global RA, Packaging Group, Global Quality
    • Regional RA and Country RA teams
    • Consultants and Distributors
    • Government Agencies, Medical/Regulatory Authorities
  • Review and approve pharmaceutical product labels or artworks for production
  • Review and approve repack and relabel instruction for pharmaceutical products
  • Provide consultations to resolve the problems or incidences due to the regulations change
  • Understands and will abide by ISMS policy and processes of the company

Education & Experience

Education:

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

Experience:

  • 5 years related work experience in Pharmaceutical and Medical Device Field
  • Familiar with the Life Sciences Industry, preferably Regulatory
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices in India, Sri Lanka and Bangladesh is a must
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Must be able to interact with internal Client teams and manufacturing site personnel in a professional manner
  • Work experience with Western Multi-National Companies in Pharmaceutical/Medical Devices fields
  • Must be familiar with Regulatory environment, and have an understanding of labeling regulations and controls
  • Strong project management and organizational skills
  • Individual must be flexible and capable of prioritizing projects, meeting deadlines, and working well under pressure

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Hands on person with a flair for Strategy formulation
  • Good knowledge of strategy development and implementation Techniques
  • Be a People Person & be able to weave into the Organization seamlessly
  • 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 Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Please make sure you have the relevant work visa prior to applying

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