Regulatory Affairs Specialist

vor 3 Wochen

Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

Job Title: Regulatory Affairs Specialist - Medical Devices

At Envista, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory 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
  • Support development projects for RA aspects, creating development-related and technical documentation for medical devices
  • 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.

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