Regulatory Affairs Specialist Leadership Position

3 days ago


Istanbul, Istanbul, Turkey Solventum Full time

Solventum is a pioneer in game-changing innovations at the intersection of health, material, and data science, creating breakthrough solutions for our customers' toughest challenges. As a Senior Regulatory Affairs Specialist, you will be part of a team that ensures every solution created meets the highest standards of quality and safety.

The ideal candidate will have scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education, with extensive experience in regulatory affairs in the medical device or pharmaceutical industry. Knowledge of regulations and standards including EN ISO 13485, EU MDR 2017/745, GMP, etc. is essential for this position.

About Solventum's Vision:

  • We enable better, smarter, safer healthcare to improve lives.
  • We pioneer innovative solutions that change patients' lives for the better while enabling healthcare professionals to perform at their best.
  • We never stop solving for you.

Key Responsibilities:

  • Acting as liaison between design center regulatory affairs, regulatory consultants and distributors to enable registrations in select EMEA countries.
  • Managing compliance projects, developing and implementing regulatory strategies and submissions for medical devices in select EMEA countries.
  • Ensuring compliance with country regulatory requirements for market access and vigilance of medical devices.
  • Implementing regulatory strategies during product development/introduction and/or product modification, ensuring all changes reflected in country registrations including correct labeling.
  • Preparing and maintaining regulatory documents for registration submissions.
  • Communicating to authorities, notified bodies, consultants and distributors etc.
  • Preparing country-specific documentation requests for registrations, bid & tenders & reimbursement.
  • Monitoring emerging regulations affecting medical devices in select EMEA countries.


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