Regulatory Affairs Manager

Vor 4 Tagen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Join Our Team as a Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs Manager to support our global team in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

Key Responsibilities:
  • Coordinate external service providers to support clinical evaluation documentation, PMCF, and PMS
  • Support risk analysis and study planning for CE and PMCF studies
  • Develop and maintain knowledge of regulatory medical writing and database management
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
Requirements:
  • Professional experience in the medical device environment or another regulatory field of work
  • Experience in literature search and review, as well as knowledge of regulatory medical writing
  • Knowledge of database management and IT affinity
  • Fluent written and spoken English
What We Offer:
  • International mobile working
  • Attractive ways of combining work and family life, e.g., childcare subsidy
  • 30 days paid leave per year, plus special leave for exceptional life events
  • Company pension plan with attractive employer contribution
  • Various health and fitness offers, e.g., skin cancer screenings, online courses for mental health

Apply now via our online platform to become part of our global team and contribute to ensuring the highest standards of medical device compliance.

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