Scientific Clinical Evaluation Manager

vor 1 Woche


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

Company Overview

At PAUL HARTMANN AG, you have the opportunity to become part of a global team. We offer a challenging position in an international environment where you can develop your skills and play an active role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.

About Us

We are a leading international medical technology company that develops and manufactures innovative wound management solutions. Our products are used in hospitals and by healthcare professionals around the world.

The Role

We are seeking an experienced Scientific Clinical Evaluation Manager to join our Regulatory Affairs team. As a key member of this team, you will be responsible for providing and updating documentation of clinical evaluation, post-market clinical follow-up, and post-marketing surveillance. You will also coordinate external service providers to support clinical evaluation documentation, PMCF, and PMS.

Your 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

About You

To be successful in this role, you will need a university degree in life science/natural science or an equivalent qualification. You should have professional experience in the medical device environment or another regulatory field of work. Knowledge of regulatory requirements, MDR, and relevant MDCGs is essential, as well as experience in literature search and review and knowledge of regulatory medical writing.

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
  • $90,000 - $110,000 per year, plus 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)
  • 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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