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Regulatory Affairs Manager

Company

headcount | recruitment driven by science

Location

basel, basel stadt

Type

Full-time

Our client operates across In Vitro Diagnostics and is looking for a hands‑on Regulatory Affairs Manager to support product registrations, submissions, and regulatory compliance activities.

Responsibilities

  • Maintain regulatory dossiers and technical documentation.
  • Support global product registrations and submissions.
  • Respond to health authority requests.
  • Review and implement regulatory requirements.
  • Provide regulatory support to cross‑functional projects.
  • Ensure ongoing regulatory compliance.

Requirements

  • Degree in Life Sciences, Engineering, or a related field.
  • 3–5 years of Regulatory Affairs experience.
  • Hands‑on experience with dossier maintenance, submissions, and technical documentation. Experience in Pharma, IVD/IVDR, and/or Medical Devices.
  • Independent, pragmatic, and solution‑oriented mindset.
  • German (B2+) and fluent Engl...

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