Regulatory Affairs Manager for Post-Market Surveillance

vor 4 Wochen

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

We are seeking a highly skilled Regulatory Affairs Manager to join our team at PAUL HARTMANN AG. As a key member of our regulatory team, you will be responsible for ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

Key Responsibilities:
  • Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance
  • Cross-functional communication with other departments such as 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
  • Provide searches in relevant vigilance databases
  • Support for 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 your stakeholders
  • IT affinity and proficiency with the MS Office package
  • Fluent written and spoken English
What We Offer:
  • Flexible working conditions, such as 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

Shape a career that's focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform.

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