
Global Regulatory Affairs Manager
18 hours ago
Solventum is a forward-thinking organization that empowers its employees to drive innovation and excellence. Our company culture values diversity, creativity, and continuous improvement, providing a dynamic environment where talented professionals can grow and thrive.
We're seeking a highly skilled and experienced professional to join our team as a Senior Specialist Regulatory Affairs (m/f/*). This role offers an exciting opportunity to leverage your expertise in regulatory affairs to shape the future of healthcare.
The Impact You'll Make in this Role- 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 labelling
- 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.
To achieve success in this role, you'll need (at a minimum) the following qualifications:
- Scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.
- Proven experience in regulatory affairs in the medical device or pharmaceutical industry.
- Ideal background includes knowledge of medical device regulations and standards such as EN ISO 13485, EU MDR 2017/745, GMP, etc.
- Able to work collaboratively in cross-functional and cross-cultural teams
- Excellent communication and problem-solving skills
- Able to interact with regulatory agencies and notified bodies
- Able to utilize databases and regulatory submission request tools
- Fluent English language skills, both written and verbal
- Bonus points for additional EMEA languages
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