Open positions

Regulatory Affairs Specialist M/F

Post on:

Monday, March 8th


Montpellier (France)



Contract type:

Permanent Contract (CDI)



  • Education: Engineering Degree or MS in Regulatory Affairs or Medical/Scientific field
  • Experience: A first successful experience in a similar position
  • Desired experiences: Work on a complex medical device including software, hardware and robotics

Job Summary

Regulatory Affairs Specialist M/F

The Regulatory Affairs Specialist reports directly to the Quality and Regulatory Affairs Manager to register the device on targeted markets.
The candidate should have a first experience within the Medical Device Industry. The missions will evolve with the Company’s growth and the various projects to come.


Key Responsibilities
  • Participate in the preparation and follow-up of medical device registration applications for the targeted US/Europe/China markets (registration applications, amendments, etc.).
  • Maintain registrations after the product release.
  • Ensure communication with competent authorities.
  • Participate in communication with clients regarding regulatory requests.
  • Work in collaboration with quality, marketing, R&D departments to ensure compliance with regulatory requirements.
  • Carriers out regulatory monitoring.


  • You have an Engineering Degree or MsC in Regulatory Affairs or Medical/Scientific field.
  • You have a good knowledge of quality and regulatory environment: ISO13485, 21CFR80, MDD93/42, MDR 17/745, 510k, IEC60601 et collateral.
  • You have a normative knowledge of active medical devices and software.
  • You have excellent organization and communication skills.
  • You are rigorous and have analytical and synthesis skills.
  • You are able to communicate effectively and build relationships with internal/external stakeholders.
  • You have strong team spirit.
  • You are highly proficient in English (written and spoken).


Working at Quantum Surgical means:
  • Joining a talented, dynamic and multicultural team whilst being part of the technological and human adventure for a company in full evolution.
  • Sharing our culture of innovation, team spirit and result-oriented
  • Taking up technical challenges
  • Benefiting from a competitive compensation (fixed salary+ variable, BSPCE)

Diversity is one of our strong beliefs. We therefore carefully study every application without any consideration that could be related to either physical or moral characteristics.

If you think you may be a good match 

Send us your information

Send us your name, email address, the job title you are applying for and a text version of your resume :