441 days ago on axepta.ch

Senior Regulatory Affairs Expert Medical Device


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Senior Regulatory Affairs Expert Medical Device

Senior Regulatory Affairs Expert Medical Device

Your Responsibilities:

  • Manage large-scale international projects, including the US
  • Be the privileged contact with the health authorities on the part concerning you and answer their questions.
  • Draft and update EC marking dossiers for several countries
  • To be in contact with the different departments for the projects you will be in charge (production, quality, etc.)
  • Prepare records for registration / renewals / changes of medical devices
  • Train and assist in the management of the team in place
  • Being the RA referent for the medical device part
  • Define the regulatory strategy for the development of new products
  • Carrying out the regulatory watch medical devices with the entity of the team responsible for regulatory affairs

Your profile:

  • Minimum 6 years experience in the field of medical device regulatory affairs 
  • Experience in CE marking
  • Having managed submission files with the US is a plus
  • Fluency in English (oral and written)
  • Be dynamic, autonomous and enjoy new challenges
  • Leadership

For more information, please contact Marine Dollat ​​at mdollat@axepta.com