Regulatory Affairs Associate

    Markham, ON, Canada

    Kelly Services just received an opening for a Regulatory Affairs Associate in Markham, Ontario.  This is a one-year assignment, 37.5 hours per week. 

     

    Responsibilities include:

    • Build and maintain collaborative working relationships with local/global business partners by ensuring effective and timely communication of regulatory issues, project status and timelines.
    • Execute appropriate regulatory submission for product lifecycle management for medical devices currently marketed in Canada.
    • Management of multiple regulatory projects by ensuring accurate tracking and documentation of activities.
    • Accurate documentation and record keeping of all assigned regulatory activities.

     

    Requirements:

    • BS in life sciences is required; advanced degree (MSc or PhD) an asset.
    • Sound knowledge of Food and Drugs Act and Medical Device Regulations and relevant policies and guidelines is required.
    • Excellent verbal and written communication skills.
    • Strong project management and time management skills.
    • Detail-oriented and ability to multi-task.
    • Excellent analytical problem-solving skills.
    • Proficient with Microsoft Office tools.

     

    Preferences:

    • Completion of Post Graduate training in Regulatory Affairs - RAC (Regulatory Affairs Certification) preferred.
    • Regulatory affairs experience in preparation of medical device submissions is preferred.
    • Experience in managing regulatory submission activities is preferred.

     

    If you are interested, please send me a recent MS Word resume.  We are limited to two submissions at this time so please don’t delay!


    Category: Biotechnology & Pharmaceutical

    Reference ID: CA768JGR000039

    Date Posted: 11/10/2019

    Shortcut: http://jobs.en.kellyservices.ca/ngXTFL

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