Regulatory Affairs Specialist

Are you a Regulatory Affairs Specialist interested in taking the next step in his career and ready to join a company that values innovation and excellence?

Do you want to work for a fast-growing spinal implant company and be a key player in our mission to deliver top-tier products that make a difference?


If yes, come to join our Regulatory team

to ensure adherence to local and international regulatory requirements!


 As Regulatory Affairs Specialist you’ll play a pivotal role in ensuring our products meet all necessary regulatory requirements. You’ll collaborate with cross-functional teams and navigate complex regulatory landscapes.


Your main responsibilities will be to manage the regulatory activities required to market medical devices and maintain registrations worldwide:

  • Support the preparation and maintenance of the registration files.
  • Maintain regulatory databases up to date.
  • Monitor registrations’ lifecycle in the Registration Information Management System.
  • Participate in writing and updating MDR Technical Documentation.
  • Participate in writing 510(k) upon manager’s demand.
  • Work on cross-functional teams; R&D, marketing, and manufacturing to advise the regulatory impact of proposed regulatory changes & transfers.
  • Interact with foreign agents, distributors, and competent authorities to monitor and manage registrations’ lifecycle worldwide
  • Support the preparation of PMS/PSUR reports for products.
  • Participate to internal audits and toexternal audits from Notified Bodies or Foreign competent authorities.
  • Participation to RA survey through impact studies for new standards
  • Participate in gathering, analysing, and interpreting Regulatory Metrics and Key Performance Indicators

Your profile:

  •  Minimum 3 years of recent experience in Regulatory Affairs
  • Experience within medical device industry with expertise on the Medical Device Regulation
  • Strong communication Skills, with the ability to effectively convey information to diverse audiences
  • Good writing skills (structured documentation such as protocols and reports)
  • Ability to document, compile and maintain complex files
  • Able to work in English and French

We look forward to receiving your application at