Medical Device Regulatory Compliance Specialist

3 days ago


Istanbul, Istanbul, Turkey Solventum Full time

Solventum is a global leader in the creation of innovative medical devices, dedicated to improving lives through better, smarter, and safer healthcare solutions. As a Senior Regulatory Affairs Specialist, you will join a team that shares your passion for excellence and commitment to quality.

The ideal candidate will have experience in regulatory affairs in the medical device or pharmaceutical industry, with knowledge of regulations and standards including EN ISO 13485, EU MDR 2017/745, GMP, etc. Strong problem-solving skills and the ability to think critically are essential for this position.

About Solventum's Global Presence:

  • We operate globally, with a presence in key markets across the globe.
  • We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
  • We enable healthcare professionals to perform at their best.

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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