Regulatory Affairs Specialist CE Marketing

AXEPTA SA
place
Genève

2T

Online bewerbenopen_in_new

We are looking for a Regulatory Affairs Specialist, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva.

Regulatory Affairs Specialist CE Marketing

We are looking for a Regulatory Affairs Specialist, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva.

Responsibilities:

This position will be focused on the registration of Class III medical devices in EU.

Your main responsibilities will be:

  • Prepare and write Technical Documentation according to MDR
  • Ensure the follow-up of registration procedures, prepare and manage timely submissions of responses to questions from these Competent Authorities
  • Work with the team in the Regulatory evaluation of changes (Change Control) and Manage the maintenance of registration dossiers (modifications and renewals)

You also will have to define the regulatory strategy of the development of new products, prepare and support audits and work as the regulatory affairs representative in the project teams.

Your profile:

  • Minimum 3 years of similar experience in medical devices or pharmaceuticals industries
  • Good knowledge of submissions to EU regulatory authorities and CE Marketing
  • Fluent in English and French
Kontakt
QUAI DU SEUJET 12 1201 Genève