Regulatory Affairs Clinical Manager for Medical Device Compliance

vor 1 Woche


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

We are seeking an experienced Regulatory Affairs Clinical Manager to join our team at PAUL HARTMANN AG. This challenging position involves ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

The successful candidate will have a strong understanding of regulatory requirements, MDR and relevant MDCGs, and rel. MEDDEVs. Additionally, they will possess experience in literature search and review, as well as knowledge of regulatory medical writing.

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.
  • Conduct literature searches and reviews in accordance with MDR/MEDDEV 2.7.1 rev. 4
  • Provide searches in relevant vigilance databases
  • Support for risk analysis and study planning for CE and PMCF studies
Qualifications and 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
  • Strong knowledge of regulatory requirements, MDR and relevant MDCGs, and rel. MEDDEVs
  • Experience in literature search and review, 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
Benefits
  • 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
  • $85,000 - $110,000 per year, depending on experience and qualifications
  • 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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