About the role

  • Responsible for the approval and registration of our medical devices (Class I/IIa under the MDR) and participation in dietary supplements/cosmetics
  • Preparation, maintenance and review of technical documentation
  • Ensuring compliance with all relevant regulatory requirements
  • Review and approval of packaging and promotional materials
  • Close collaboration with internal departments, external consultants, authorities and Notified Bodies
  • Active monitoring of regulatory developments and identification and implementation of necessary actions
  • Support during audits and inspections and assistance to Quality Management

Requirements

  • Degree in Pharmacy, Chemistry, Biology, Medical Engineering, Food Chemistry or a related field
  • Professional experience in Regulatory Affairs, ideally with a focus on medical devices
  • Knowledge of dietary supplements and cosmetics is an advantage
  • Strong knowledge of relevant EU regulations/standards
  • Experience in liaising with authorities/Notified Bodies
  • Excellent spoken and written German and English

Benefits

  • Coffee, tea & water – unlimited during working hours
  • Team events – we promote team spirit because we are stronger together
  • Option to work in a mobile office (remote/hybrid work option)
  • Birthday gift – because everyone is special
  • Company pension scheme – thinking of tomorrow today
  • Subsidy for computer glasses – so everything is clear and easy to read
  • E-bike/bike leasing – cycle to work
  • eGym Wellpass – promoting your well-being
  • Special leave – for various occasions such as birth, marriage, bereavement
  • 30 days of annual leave per year

Job title

Regulatory Affairs Manager

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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