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Regulatory Affairs Specialist
vor 2 Monaten
Job Title: Senior Regulatory Affairs Specialist
Job Summary:
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Envista. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.
Key Responsibilities:
- Coordinate projects to implement new regulatory requirements, such as MDR (EU) 2017/745, and support other departments to comply with these regulations.
- Support 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.
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.
About Us:
Envista is a leading company in the medical technology industry, with a strong commitment to innovation and regulatory compliance. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.
