Clinical Evaluation Manager

vor 1 Monat

Heidenheim, Deutschland PAUL HARTMANN AG - Karriere Vollzeit
Unlock Your Potential in Regulatory Affairs

At PAUL HARTMANN AG - Karriere, we're committed to helping healthcare professionals grow and thrive in their careers. As a Manager Regulatory Affairs Clinical, you'll play a vital role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

Key Responsibilities:
  • Develop and maintain clinical evaluation documentation, post-market clinical follow-up, and post-marketing surveillance
  • Collaborate with cross-functional teams, including Marketing and R&D, to ensure required input documentation is up-to-date
  • Coordinate external service providers to support clinical evaluation documentation, PMCF, and PMS
  • Determine clinical evidence requirements according to MDR and relevant MDCGs
  • Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs
  • Conduct literature searches and reviews in accordance with MDR/MEDDEV 2.7.1 rev. 4
  • Provide searches in relevant vigilance databases
  • Support risk analysis and study planning for CE and PMCF studies
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
  • Knowledge in regulatory requirements, MDR, and relevant MDCGs, rel. MEDDEVs
  • Experience in literature search and review required, as well as knowledge of regulatory medical writing
  • Knowledge of database management
  • Open and competent attitude when working with stakeholders
  • IT affinity and proficiency with the MS Office package
  • Fluent written and spoken English
What We Offer:
  • Flexible working conditions, including flexible working hours and mobile working
  • 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, incl. matching model for deferred compensation
  • Plenty of parking spaces, canteen with café bar, and ongoing offers in the employee shop
  • Access to over 6000 fitness and yoga studios, swimming pools, as well as Crossfit and bouldering halls (EGYM Wellpass)
  • 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

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