- 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
- 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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