Clinical Evaluation Manager

vor 1 Woche

Ulm, Baden-Württemberg, Deutschland HARTMANN Vollzeit

At HARTMANN, we're committed to helping healthcare professionals focus on what matters most: positively impacting people's lives. We support our team members in realizing solutions that make a difference. As a Clinical Evaluation Manager, you'll play a key role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

Responsibilities:

  • Provide and update documentation of clinical evaluation, post-market clinical follow-up, and post-marketing surveillance
  • Cross-functional communication with other departments 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

Qualifications:

  • University degree in life science or 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

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
  • 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 6,000 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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