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 external 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
https://spineart.bamboohr.com/careers/54?source=aWQ9MTg%3D