
Senior Regulatory Affairs Professional
4 days ago
Solventum is a leading innovator in the healthcare industry, dedicated to creating breakthrough solutions for our customers' toughest challenges. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with country regulatory requirements for market access and vigilance of medical devices.
The successful candidate will have extensive 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 communication and decision-making skills are essential for this position, as well as the ability to negotiate with regulatory agencies and notified bodies.
About Solventum:
- We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
- Our team is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.
- We value diversity at our company and do not discriminate on the basis of race, religion, gender, age, civil status, disability, family status, or membership of the travelling community.
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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