Open positions

Regulatory Affairs Specialist M/F

Post on:

Monday, March 8th

Place:

Montpellier (France)

When:

ASAP

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.

 

Profile
  • 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.

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