Clinical Evaluation Manager

vor 1 Woche

Ulm, Baden-Württemberg, Deutschland HARTMANN Vollzeit

Job Summary

HARTMANN is seeking a highly skilled Clinical Evaluation Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the proper execution of clinical evaluation procedures for medical devices.

Key Responsibilities

  • Provide and update documentation of clinical evaluation, 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.

Benefits

  • 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, including a 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).
  • Variety of 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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