Our client is a leading manufacturer of advanced and high-quality medical devices. They are currently looking for a Senior Regulatory Affairs Specialist to join their team.
The incumbent will oversee filing, complaint and recall reporting, and product management from a regulatory perspective. The position will communicate with customers, global corporate partners, and external regulatory bodies.
- Provide regulatory assessments for testing activities and complete reports for proposed changes
- Conduct regulatory reviews for deviations, non-conformities, CAPA, complaints and recall activities
- Prepare regulatory submissions to Health Canada
- Work collaboratively with R&D, Quality, Clinical and Operations teams
- Maintain knowledge of Health Canada and FDA/global regulatory requirements
- Serve has the regulatory representative to regulatory agencies
- Other tasks as assigned
- University degree in a Life Science discipline
- Diploma/certificate in Regulatory Affairs
- 5+ years of regulatory experience in the medical device industry
- In-depth knowledge of Canadian Medical Devices Regulations and Guidelines for licenses of Medical device products
- Experience with international product registrations is a strong asset
To apply, please submit your resume to Bryan Forrest using the “Apply Now” button.
We thank all interested applicants, however only qualified candidates will be contacted.