Regulatory Affairs Coordinator

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Provide accurate, relevant, and timely information internally and externally, to support the vigilance process and regulatory activities.

RESPONSIBILITIES INCLUDE:

REGULATORY AFFAIRS SUPPORT
  • As directed, assemble documents for regulatory submissions
  • Receive customer feedback information from Customer Service staff
    • Inspect product and/or information to determine what has happened, and what action is required
    • Initiate appropriate action
  • Track customer feedback information, and conduct trend analyses
  • Report trends in internal product feedback and feedback on related external products, to promote continuous improvement
  • Act as authorized back up to approve lot production releases
  • Provide other support as required or requested by Regulatory Affairs staff
HEALTH AND SAFETY
  • Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
POLICY COMPLIANCE
  • Adhere to all relevant policies, procedures and legislation
SUPPLEMENTARY
  • Perform special projects as required
  • Participate in ongoing training and professional associations as appropriate
  • Fully utilize TMI resources to ensure delivery of a quality product to all internal and external customers at a minimal cost
  • Provide Reception coverage as part of a schedule
QUALIFICATIONS:
  • College diploma or university degree in health or biological sciences
  • Two years administrative work experience
    • Experience in a medical device or pharmaceutical environment is an asset
  • Computer literate with:
    • Advanced experience in a Windows environment
    • Advanced experience in MS Word
    • Advanced experience in MS Excel
    • Basic knowledge of Enterprise Resource Planning (ERP) software, e.g. Great Plains Dynamics
  • Experience using database software to manage data and records is an asset
  • Strong organizational and general administrative skills
  • Demonstrated attention to detail
  • Strong interpersonal skills with ability to communicate effectively with internal personnel and external parties, e.g. customers
  • Knowledge of the requirements of an ISO 13485 quality program is an asset
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