Senior Regulatory Affairs Specialist

  • Senior Regulatory Affairs Specialist

    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.

    Responsibilities:
    • 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

    Requirements:
    • 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.