Overview

POSITION SUMMARY:

Premarket:

  • Independently assess the acceptability of information including quality, preclinical and clinical documentation for submission filing, and perform risk-benefit analysis for regulatory premarket strategy.
  • Compile and submit regulatory submission to health authorities with minimal supervision, including class II, III and IV medical devices, drugs, natural health product (NHP), and cosmetics..
  • Manage communications with Health Canada on submission files and subsequent negotiations necessary to obtain and maintain marketing authorizations.
  • Provide regulatory input to the development of Quality Agreements
  • Maintains all documentation in accordance with Good Manufacturing Practices requirements stipulated in the Food, Drugs Act and Regulations.
  • Monitor for regulatory changes to applicable regulations and requirements and communicate changes across the organization.
  • Exchange and convey regulatory requirements and provide strategic and technical advice to appropriate stakeholders during the product lifecycle

Postmarket:

  • Review proposed changes to medical device, drug, natural health product and cosmetics and assess and communicate possible regulatory impacts.
  • Review promotional materials (i.e. brochures, catalogues, websites, etc.) to ensure regulatory compliance for Canadian market.
  • Maintain annual facility and/or licenses and registrations.
  • Provide regulatory input for rework process for class III and IV medical devices in Canada

KNOW HOW AND EXPERIENCE

  • Applied comprehensive knowledge of the Food and Drugs Act and Canadian Medical Devices Regulations, Natural Health Product regulations, GMP requirements, Cosmetics and Consumer Regulations.
  • Bachelor’s degree required, strongly preferred in the biological sciences, chemistry or related science
  • + 5 years of experience in regulatory affairs in the medical device or pharmaceutical industry
  • Experience filing medical device, drug, natural health product and cosmetics submissions in Canada.
  • Certification in regulatory affairs program preferred
  • Must be able to multi-task and manage priorities with minimal supervision
  • Ability to analyze complex situations and provide regulatory solutions using risk based methodology.
  • Ability to effectively collaborate and communicate with internal and external stakeholders.

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