Regulatory Affairs Manager

vor 2 Wochen

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

We are seeking a highly skilled and experienced Manager Regulatory Affairs Clinical to join our global team at PAUL HARTMANN AG. As a key member of our regulatory affairs team, you will play a crucial role 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 implement regulatory strategies to ensure compliance with relevant regulations and guidelines
  • Collaborate with cross-functional teams to ensure effective communication and coordination
Requirements:
  • University degree in life science/natural science or an equivalent qualification
  • Professional experience in the medical device environment or another regulatory field of work
  • Experience in literature search and review required as well as knowledge of regulatory medical writing
  • Knowledge of database management
  • IT affinity and proficiency with the MS Office package
  • 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 as well as vacation pay and special annual payment according to collective agreement
  • Company pension plan with attractive employer contribution
  • Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
  • Job Bike Leasing
  • Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform

Apply now via our online platform to take the first step towards an exciting career opportunity at PAUL HARTMANN AG.

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