Regulatory Affairs Specialist

vor 2 Wochen

Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

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 department, you will be responsible for coordinating projects to implement new regulatory requirements and supporting other departments to comply with these regulations.

Key Responsibilities:

  • Coordinate projects to implement new regulatory requirements and support other departments to comply with these regulations.
  • 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.

About Us:

Envista is a leading company in the biomedical industry, with a strong focus on innovation and regulatory compliance. We are committed to providing our customers with high-quality medical devices that meet the highest regulatory standards.

  • Regulatory Affairs Specialist

    vor 1 Monat

    Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

    Job Title: Senior Regulatory Affairs SpecialistJob 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 Affairs Specialist

    vor 1 Monat

    Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

    Job Title: Senior Regulatory Affairs SpecialistJob 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 Affairs Specialist

    vor 3 Wochen

    Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

    Job OverviewMatricel GmbH, a subsidiary of Nobel Biocare, is a leading biomedical company with global operations. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key ResponsibilitiesCoordinate projects to implement new regulatory requirements, such as MDR (EU) 2017/745, and support other departments in complying with these...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

    Job Title: Regulatory Affairs Specialist - Medical DevicesAt 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...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

    Job Title: Regulatory Affairs Specialist - Medical DevicesJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Envista. As a Regulatory Affairs Specialist, you will be responsible for coordinating projects to implement new regulatory requirements and supporting other departments to comply with these regulations.Key...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Herzogenrath, Nordrhein-Westfalen, Deutschland Envista Vollzeit

    Job Title: Regulatory Affairs Specialist - Medical DevicesMatricel GmbH, a fast-growing biomedical company, is seeking a Regulatory Affairs Specialist to join its team. The successful candidate will be responsible for coordinating projects to implement new regulatory requirements and supporting other departments to comply with these regulations.Key...

  • Senior Regulatory Affairs Specialist

    vor 5 Monaten

    Herzogenrath, Deutschland Envista Vollzeit

    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...