Regulatory Affairs Specialist – Medical Devices

Reference Number: 875421-W
Type of placement: Contract, 12 months
Location: CH, NW

Introduction:

To contribute to a dedicated, cross functional and energetic project team implementing the new EU Medical Device Reporting (MDR) requirements.

Main Responsibilities:

  • Organize and implement strategies and activities required to procure regulatory approval for new and revised product lines.
  • Ensure compliance to all US, EU and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products.
  • Contribute to ensuring safety and efficacy on a wide range of products.
  • Prepare regulatory submissions dossiers and follow-up with FDA and other regulatory agencies on submissions, approvals or related matters.
  • Support R&D, marketing and manufacturing teams in regulatory assessment of proposed changes or product transfers.
  • Provide regulatory support in cross functional team activities, as required.

Qualifications and Experience:

  • Bachelor’s Degree in a scientific discipline. Ideally, you dispose of a RAC certification.
  • 2-3 years’ experience in a highly regulated industry and working knowledge of Medical Device Regulations (FDA/MDD required, additional international a plus).
  • Experience with 510(k), EU MDD 93/42/EEC Technical File/Design Dossier preparation.
  • A successful track record interacting with FDA and notified body reviewers/inspectors.
  • Fluent in both written and spoken English. Any additional language is an asset.
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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