Regulatory Affairs Expert

Vor 3 Tagen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

We are seeking a highly skilled Regulatory Affairs Manager to join our global team at PAUL HARTMANN AG. In this role, you will play a crucial part in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

Key responsibilities will include:

  • External Service Coordination: Coordinating external service providers to support clinical evaluation documentation, PMCF, and PMS.
  • Risk Analysis and Study Planning: Supporting risk analysis and study planning for CE and PMCF studies.
  • Regulatory Expertise: Professional experience in the medical device environment or another regulatory field of work, with knowledge of regulatory medical writing, literature search, and review.
  • IT Affinity and Database Management: IT affinity and proficiency with the MS Office package, with knowledge of database management.
  • Language Skills: Fluent written and spoken English.

As a Regulatory Affairs Manager at PAUL HARTMANN AG, you will have the opportunity to develop your skills and work in an international environment. Our company offers a range of benefits, including:

  • International Mobile Working
  • Attractive Work-Life Balance
  • Company Pension Plan
  • Health and Fitness Offers
  • Job Bike Leasing

Apply now via our online platform.

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