• Location


  • Sector:

    Regulatory Affairs, Quality

  • Salary:

    60000 EUR, paid in 12 month installments, plus employer pension contribution

  • Contact:

    Rebecca Stevens

  • Job ref:


Medical Device - Regulatory & Quality Manager / Product Management - Class ll/ Class lll

Company Information:

our client is an innovator in intraoperative devices for neurosurgery and neuropathology, with their research deemed as pioneering. They continue to research and develop safety enhancing tools for doctors and patients alike. They have a long-established history in their field, with over 30 years of operation, with current distribution across international markets. Despite this, being a family-owned business , they maintain the culture of smaller people centric firms. Operating from the Freiburg Area they employ 250 people and are looking to expand for 2022. At this exciting time of their growth, they are looking for an RA/QM manager to help with their MDR transition for their Neuromonitoring line of products, while providing the candidate with the opportunity to get involved with product management.

The opportunity:

  • RA responsibilities: Help with their MDR transition: including help with technical files, registration and liaising with notified bodies.

  • QM responsibilities: Help with creating and maintaining the Risk Management (RM) and Post Market Surveillance (PMS) procedures.

  • Product Management Opportunity/Training: Their EU regulatory and quality functions sits in conjunction with their product management team. They are offering the unique opportunity to learn, and take on, project management responsibilities. You will be supported by the director for development who will help you transition into this aspect of the role over a two-year period so experience in product management is not necessary.

  • Product Management responsibilities include change management, development of product concepts and elaboration of customer requirements for new products in cooperation with R&D team and external partners.

  • Culture: They work to a flat hierarchy, offering you the chance to progress on merit without pre-determined barriers. Their culture is driven by the need to continuously innovate in neuromonitoring. You will be the right cultural fit if you are interested in a company who invests in research and innovation. They identify as a people centric business where they operate as a large company with a small family business feel.

Extra Information:

  • 250 employees currently in Germany, with recognition for pioneering research.

  • Flexible working pattern, ideally looking to offer 50% from home working opportunity

  • Cycle to work scheme

  • People centric company culture

  • Employer pension contribution

To apply please contact Alex Coveney-Alym 
Medical Device Recruitment Specialist - DACH
Email: alex.coveney-alym@adaptivelifescience.com

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