Regulatory Affairs Specialist

Union: Non-Union
Number of vacancies: 1
New or Replacement Position: Replacement
Site: 2400 Skymark Ave. Unit 3, Mississauga, Ontario L4W 5K5
Department: Quality and Regulatory
Reports to: Regulatory Affairs Manager
Salary Range: $65,000-$80,000 annually
Hours: 40 Hours per week
Shifts: Monday to Friday
Status: Permanent Full-Time
Closing Date: October 15, 2026

Position Summary:

The Regulatory Affairs Specialist is responsible for supporting and maintaining regulatory compliance for medical devices across global markets, including Canada, the United States, the European Union, and other regulated jurisdictions. This role prepares and manages regulatory submissions, maintains product and facility licenses and registrations, supports responses to regulatory authorities, and ensures ongoing compliance with applicable regulations and quality standards such as ISO 13485, MDSAP, EU MDR, and FDA requirements.

The incumbent will also contribute to post-market surveillance activities, complaint assessment and adverse event reporting, regulatory impact assessments for product changes, and audit support. Working closely with cross-functional teams, the Regulatory Affairs Specialist helps ensure that products remain compliant throughout their lifecycle while supporting the organization's quality and regulatory objectiv

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.

What We Offer

• Opportunity to work at the forefront of organ transplantation innovation.
• Direct interaction with leading transplant programs across North America.
• Exposure to clinical development, product commercialization, and medical education.
• Collaborative, mission-driven environment focused on improving patient outcomes.
• Competitive salary, benefits, and opportunities for professional growth.