Regulatory Affairs Manager

vor 3 Wochen


St Gallen, Sankt Gallen, Schweiz headcount | recruitment driven by scientists Vollzeit

My client needs your expertise to drive international registrations for their Class I and II devices. We are looking for an experienced (Minimum 3 years) RA Specialist/Manager to independently take on expansion and maintenance projects. This is a global role covering 140 countries, and with a great team/affiliates to support you in your transition.

3 or 4 days (Project Dependent) on-site role. Please consider this before applying.

Your role:

  • Oversee global registration of medical devices, with the support of local affiliates
  • Prepare and maintain authorization dossiers and documents
  • Handle inquiries from authorities and partner companies
  • Support audits conducted by international authorities
  • Conduct regulatory review and approval of commercial products

Your Profile:

  • Minimum Bachelors Education in a Medical or Engineering field.
  • EU regulatory knowledge, with at least 3 years in operational roles. Experience with international registrations will be a plus.
  • Fluent German and English
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