Work Location: 2400 Skymark Ave., Unit 3, Mississauga, ON
Department: Quality and Regulatory
Reports to: Regulatory Affairs Manager
Work Model: On-site
Status: Permanent Full-time
Closing date: November 28, 2025
Duties and 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.
- Assist in preparing 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. Assist with preparation of country-specific forms for reportable incidents within the required timeline.
- Participate in any required regulatory notices, recalls and field actions, if required.
- Maintain product UDI listings in country-specific databases.
- Assist in internal and external audits, providing regulatory input as needed, and participate in writing and executing corrective action plans for audit nonconformances.
- Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.
- Participate in post-market surveillance activities for licensed products.
Education:
- Bachelor of Science Degree (or equivalent).
- Post-Graduate Degree or Certificate in Regulatory Affairs, or equivalent work experience.
Experience:
- 3+ years’ experience in medical device or biologics regulatory affairs.
Skills and Knowledge:
- 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 is an advantage.
