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Regulatory Affairs Role - Toronto - Medical Device

  • 1.  Regulatory Affairs Role - Toronto - Medical Device

    Posted 06-Oct-2023 10:37
    Hi! Happy Thanksgiving!

    Challenging role in the medical device - lab instrument sales and distribution industry - on site position in the GTA.
    Excellent salary, bonus, benefits, nurturing atmosphere.
    Please email me at hr@hessjobs.com if you wish to discuss!
    =====

    Our client sells clinical lab diagnostic equipment to core labs across Canada. They are looking for an MLT 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 an MLT who has grown into the medical device regulatory arena.
     
    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, staff training.
    REQUIREMENTS:
    • MLT background.
    • 4 to 5 years working in the regulation of medical device sale/distribution in Canada.
    • Customer focus with experience leading, mentoring others.
    • RAC designation nice to have.
    • 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