Regulatory Affairs Specialist

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 13 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.

Qualifications :

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.

Remote Work :

No

Employment Type :

Full-time