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Medical Device RA Manager Position

vor 1 Woche

Zürich, Zürich, Schweiz elemed Vollzeit
About the Opportunity

We're looking for an exceptional Senior Regulatory Affairs Specialist to join our expanding QA/RA team at elemed. The successful candidate will bring extensive regulatory expertise, excellent communication skills, and the ability to thrive in a fast-paced environment.

Main Responsibilities
  • Manage global technical documentation and ensure compliance
  • Maintain regulatory certifications, including CE mark and PMA
  • Serve as primary contact for regulatory authorities and notified bodies
  • Support senior RA professionals with regulatory tasks
  • Coordinate design control activities and develop technical documentation
  • Provide regulatory guidance for product development and remediation
  • Support electrical safety and software initiatives
  • Analyze processes and identify regulatory compliance risks
Requirements
  • At least 3 years of RA experience in the medical device industry
  • Thorough understanding of IEC 60601-1
  • CE marking expertise mandatory
  • Excellent English communication skills
What We Offer

Join our dynamic team, contribute to innovative products, and advance your career in a rapidly growing company.