Regulatory Affairs Specialist

Regulatory Affairs Specialist (m / w / d)

Based in Baden-Wurttemberg, near Karlsruhe

Our client is a global leader in medical devices for critical care, surgical and lifesaving treatments. Due to medical device product expansion and the new European regulations, they are growing the regulatory team to include a Regulatory Affairs Specialist who will focus on European registrations, and touchpoints to the FDA. With offices in more than 35 locations worldwide and a sophisticated portfolio of devices, the opportunity for development and autonomy is clear and is an exciting challenge for a Regulatory Affairs Specialist or Manager.

Your Responsibilities:

  • Strategic preparation and processing of global regulatory approvals for market-leading medical products

  • Device launches in EU/USA under the MDR and FDA

  • Management of the technical file documentation for international approvals in the EU and US

  • Collaborate on risk management for medical devices under ISO 14971

  • Development and execution of regulatory strategies

  • A close partnership with other departments for a quick and efficient product launch in multiple markets

Experience Required:

  • Degree educated in scientific studies or engineering

  • 2-3 years of experience in regulatory affairs at a medical device company

  • Working knowledge of the MDD/MDR, FDA as a bonus

  • Very good spoken and written English

  • Technical experience in engineering or quality management is a plus


Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.