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Regulatory Affairs Specialist
vor 2 Monaten
Job Overview
Envista, a leading company in the biomedical industry, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the development and distribution of innovative medical devices.
Key Responsibilities
- Coordinate projects to implement new regulatory requirements, such as the MDR (EU) 2017/745, and support other departments in complying 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's or comparable academic degree in Biomedical Science, Chemistry, Pharmacy, Natural Science, or equivalent.
- Minimum 3 years' experience as a 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 Envista
Envista is a global leader in the biomedical industry, dedicated to developing and distributing innovative medical devices. Our company values innovation, collaboration, and excellence, and we are committed to making a positive impact on people's lives.
