Discussion: View Thread

Expand all | Collapse all

Medical Device Regulatory Affairs Role - GTA

  • 1.  Medical Device Regulatory Affairs Role - GTA

    Posted 18-Dec-2023 10:10
    Hi everyone and Happy Holidays!
    ==========================

    Our client sells clinical lab diagnostic equipment to core labs across Canada. They are looking for a medical device Regulatory Affairs specialist with a background holding the responsibility for the company's regulatory compliance, licenses, compliance with regulations regarding the sale of medical devices in Canada, per Health Canada regulations. The ideal person will be a lab tech who has grown into the medical device regulatory arena.(This is not a role related to new instrument design and development.)
    Full time on site position.
     
    ROLE AND RESPONSIBILITIES:
    • Keeping Health Canada guidelines related to licenses and distribution of medical devices up to date.
    • Compliance and regulatory initiative responsibility.
    • Vendor ISO certificates, SOPs, product inserts, RFP support, complaints.
    • Radiation safety and H&S issues, audits.
    REQUIREMENTS:
    • Clinical lab tech background of interest.
    • 4 to 5 years working in the regulation / regulatory compliance of medical device sale/distribution in Canada.
    • Customer focus with experience leading, mentoring others.
    • ISO 13485:2003.


    Thanks!

    Regards,
    Paula

    Paula Strasberg, Ph.D. VP Recruiting Services
     Hess Associates  Toronto, ON
    paula@hessjobs.com 416 447 3355   
    Resume editing services available upon request