Open positions

Regulatory Affairs Specialist H/F

Post on:

Friday, July 5th

Place:

Montpellier (France)

When:

Asap

Contract type:

CDI

 

 

  • Education: MS Engineering in Regulatory Affairs, Medical fiedl or equivalent
  • Experience: 3+ years of experience in Regulatory Affairs in the Medical Device Industry

Job summary

Regulatory Affairs Specialist H/F

Quantum Surgical is looking for Regulatory Affairs Specialist (H/F) to join a team of creative and energetic engineers who are building the next generation of smart tools for minimally invasive therapies.

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 is placed on the market.
  • 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.
 
Experiences and Qualifications
  • Engineering Degree or MsC in Regulatory Affairs or Medical/Scientific field.
  • Good knowledge of quality and regulatory environment: ISO13485, 21CFR80, MDD93/42, MDR 17/745, 510k, IEC60601 et collateral. 
  • Normative knowledge of active medical devices and software.
  • Excellent organization and communication skills.
  • Rigor and analytical skills.
  • Ability to communicate effectively and build relationships with internal/external stakeholders.
  • Strong team spirit.
  • Proficient in oral and written English.

 

Desired Experiences
  • Experience in Regulatory Affairs in the Medical Device Industry.

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 :

[contact-form-7 id="1199" title="Formulaire de recrutement"]