Kelly Services Regulatory Affairs Associate - Medical Device in Toronto, Canada

Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit to learn more and view a full listing of our opportunities.



  • A graduate degree in a science or health discipline or a graduate of a community college program in a related field with equivalent work experience.

  • Minimum 2 years of experience in a multi-division work environment within the healthcare industry.

  • Knowledge and application of national and international regulatory requirements for medical devices and drugs.

  • Knowledge and application of procedures, quality systems, and the ISO 13485 standard.

  • Superior analytical, organizational and independent problem-solving capabilities.

  • Computer literacy in Adobe Acrobat, Windows, Excel, MS Office.

  • Excellent verbal, composition and written communication skills.

  • Good interpersonal skills as this function interfaces with various departments as well as external customers, suppliers and Regulatory Authorities;


  • Assist the Director of Regulatory Affairs in the establishment of systems and databases to maintain compliance to national and international regulatory requirements;

  • Assist the Director of Regulatory Affairs with the coordination of submissions for new/existing product applications for regulatory compliance;

  • Support product label / packaging development.

  • Assist in maintaining practices that comply with the importation, testing, registration, and post-sale traceability and reporting requirements for 'Company' products;

  • Provide support to the R&D department in order to ensure compliance with 'Company' manufactured product. Compliance will encompass direction of regulatory registrations, product safety testing, and testing house audit reports & data files;

  • Provide guidance to the R&D, Quality and 'Company' manufacturing facilities with the appropriate GMP requirements, Standards & Guidelines applicable to the 'Company' production sites;

  • Act in a supportive role for the Business Unit and Sales regarding regulatory needs particularly to imported product for distribution purposes;

  • Assist in the monitoring of all incoming reports which may be of an "adverse incident" nature;

  • support audit / inspection