Regulatory Affairs Manager

☞ Randstad Switzerland

View: 122

Update day: 26-03-2024

Location: Zug Zug ZG

Category: Legal / Contracts

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Do you have at least 5 years of experience in Regulatory Affairs in the medical device industry ? Would you like to work on global projects ? You should then read the following line!

One of our clients, a renowned medical device company based in the Zug area, is looking for a Regulatory Affairs Manager for a 1 year contract (extendable).

This role is responsible for activities associated with regulatory approval of in vitro diagnostic medical devices including the overall development, implementation and coordination of regulatory strategies and activities with a focus on hardware and software products and projects

Tasks
  • Project Lead Regulatory, within the scope of a project for new products or during the product life cycle
  • Provides regulatory support to the R&D Project teams with the applicable Design Control processes
  • Provides team members ad hoc specific education
  • Provides qualification and classification of the development object and related submission strategy
  • Escalates project related regulatory issues;
  • Review of labelling
  • Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflicts
  • Administration of Product declarations, Certificates and other, similar documents
  • Define and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned area
  • Ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest
  • Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. regulations or changes in the regulations)
Profile
  • Bachelor or Master Degree in Life Sciences
  • At least 5 years of experience as a Regulatory Affairs Manager for IVD Instruments
  • At least 5 years of experience with Development of IVD Devices or Medical Devices (IVDR)
  • Experience with software regulations
  • Experience in supporting development projects
  • Very good command of English is required
Do those lines trigger your interest ? Do not waste a second and apply now!
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Deadline: 10-05-2024

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