Medical Device Compliance Specialist

Vor 6 Tagen

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

We support healthcare professionals to positively impact people's lives. At HARTMANN, you have the opportunity to become part of a global team as a Manager Regulatory Affairs Clinical (f/m/d). This role offers a challenging position in an international environment where you can develop your skills and contribute to ensuring medical device compliance with relevant clinical performance and safety requirements.

  • 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
Qualification 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
Salary and Benefits

The estimated annual salary for this position is approximately €80,000 - €110,000 depending on qualifications and experience.

  • 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

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