Regulatory Affairs Expert
1 day ago
Solventum is a global leader in pioneering game-changing innovations at the intersection of health, material and data science. We're committed to improving lives by creating breakthrough solutions for our customers' toughest challenges.
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 dedicated to delivering exceptional results and making a meaningful impact in the lives of patients and healthcare professionals.
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 succeed in this role, you will require (at a minimum) the following qualifications:
- Scientific university degree (Dipl., Master, Bachelor) or a comparable qualified education.
- Extensive 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 effectively in cross-functional and cross-cultural teams
- Strong communication and decision-making skills
- Able to negotiate 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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