Senior Regulatory Affairs Specialist

Job Description

Matricel GmbH headquartered in Herzogenrath (Germany) was aquired by Nobel Biocare in 2020, a part of Envista Holdings headquartered in Brea, California (USA). Matricel GmbH is a fast growing, successful biomedical company with worldwide activities. We develop, produce and distribute innovative medical devices for clinical applications in the regenerative medicine.

Primary duties & responsibilities :

Coordination of projects to implement new regulatory requirements (i.e. MDR (EU) 2017 / 745) and supporting other departments to comply with these regulatory requirements

Supporting development projects for RA aspects, creating development-related and technical documentation for medical devices, editing existing technical documentation

Communicate and work with national and international Regulatory Affairs agencies

Support the development of national and international regulatory strategies

Initiate and implement projects for new or updated regulatory requirements to ensure continuous market access

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Job Requirements :

• Master or comparable academic degree in Biomedical Science, Chemistry, Pharmacy, Natural Science or equivalent
• Minimum 3 years´ experience as Regulatory Affairs Specialist in the field of medical technology, preferably in an international context
• In-depth knowledge of standards and regulations such as : ISO 13485, ISO 14971, 21 CFR part 820, MDSAP, MDR, international approval requirements
• Experience in registration of medical devices in Japan would be an advantage
• Creation and updating of plans & reports according to MDR (e.g. SSCP reports, PSUR)
• Languages : Fluent in English, both in conversation as well as in writing. German is an advantage.

Operating Company : Nobel Biocare

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