Regulatory Affairs Specialist

  • Publication date:

    19 März 2023
  • Workload:

  • Contract:

    Unlimited employment
  • Language:


Regulatory Affairs Specialist

For our partner in biotechnology industry, Kelly Life Sciences is looking for:

Regulatory Affairs Specialist

(Permanent contract)

Your responsibilities:

  • Verifying the conformity of IVD medical devices in accordance to the requirements of the European IVD Directive 98/79/EC and 2017/746
  • Building and updating technical documentation of IVD reagents and instruments
  • Coordination of the submission of registration files to the Notify Body
  • International coordination to define the regulatory strategy with their subsidiaries

Your profile:

  • Scientific degree in biology or pharmacy or equivalent
  • Minimum 4 years of experience in regulatory affairs and knowledge in medical devices industry is an asset
  • Knowledge of immuno hematology is an asset
  • US/FDA regulatory knowledge is an asset (BLA; 510K)
  • Good writing and communication skills
  • Languages: Fluent in English, good command of German and/or French is a plus

Your contact at Kelly: Anaïs Mieszczak and Manon Mottet

rue du Rhône 114 1204 Fribourg