Senior Regulatory Affairs Specialist

University Health Network•Mississauga, ON

9d•CA$85,000 - CA$115,000•Onsite

About The Position

Traferox Technologies Inc. is seeking a Senior Regulatory Affairs Specialist to join their Quality and Regulatory department. This new, permanent full-time position is based in Mississauga, Ontario. The role involves preparing technical documents for regulatory submissions, maintaining regulatory files for various markets (EU, US, Canada, etc.), and ensuring compliance with relevant standards and regulations. The specialist will also handle license renewals, respond to regulatory authorities, assess device complaints, lead regulatory notices/recalls, manage UDI listings, participate in audits, and oversee post-market surveillance.

Requirements

Bachelor of Science Degree (or equivalent)
Post-Graduate Degree or Certificate in Regulatory Affairs, or equivalent work experience
7+ years’ experience in medical device or biologics regulatory affairs
Experience authoring original device submissions in US, Canada, or EU
Familiarity with medical device standards and regulations such as ISO 13485, ISO 14971, EU MDR, US FDA 21CFR, Canada SOR 98/282
Excellent written and verbal skills
Excellent organization and file management skills
Proficient with Microsoft office products
Adaptable, able to work both independently and with high performance teams
Ability to consume and understand technical and clinical information to support regulatory filings and summaries
Exposure to complaint handling and adverse event reporting

Responsibilities

Prepare technical documents to support market-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
Maintain regulatory files for EU, US, Canada, and other regulated markets, ensuring that files are updated to reflect current products and standards.
Maintain company facility and product licenses and registrations in all active jurisdictions including renewals, device listings, site registrations, supplements for changes and annual reports.
Prepare responses to regulatory authorities’ questions within assigned timelines.
Stay abreast of updates to regulations and standards. Perform gap analyses and make required changes in Traferox procedures as required. Maintain procedures in compliance with ISO 13485 and MDSAP requirements.
Assess device related complaints for medical device reporting requirements. Prepare country-specific forms for reportable incidents within the required timeline.
Lead any required regulatory notices, recalls and field actions.
Maintain product UDI listings in country-specific databases.
Participate in internal and external audits, providing regulatory input as needed. Coordinate writing and executing corrective action plans for audit nonconformances related to regulatory functions and documents.
Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.
Oversee post-market surveillance activities for licensed products.