The Opportunity

This position is based in Mississauga, Ontario, within the ADD (Diagnostics) division, with occasional travel (~5% domestic and international).

As a Regulatory Affairs Specialist, you will support regulatory activities for diagnostic products to ensure compliance with Canadian regulations. You will contribute to regulatory submissions, product lifecycle support, and cross-functional collaboration.

This role is ideal for a detail-oriented professional who thrives in a fast-paced, matrixed environment.

What You’ll Do

Regulatory Submissions

• Coordinate and prepare regulatory submissions for diagnostic and distributed products
• Respond to Health Canada requests for additional information
• Prepare and submit annual license renewals (medical device and establishment licenses)

Compliance & Regulatory Assessment

• Conduct regulatory assessments for product changes
• Support Summary Report activities
• Assess impact of emerging regulations
• Ensure labeling, advertising, and promotional materials comply with regulations

Product Support & Audits

• Support product release processes and approvals
• Review protocols and reports for regulatory activities
• Support internal and external audits

Collaboration & Operations

• Maintain regulatory submission databases and trackers
• Interface with Health Canada when required Collaborate with internal teams and external stakeholders
• Maintain effective and professional communication

Additional Responsibilities

• Support company initiatives
• Ensure compliance with regulations, SOPs, and policies
• Perform other duties as assigned

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 1–3 years of relevant regulatory experience
• Experience preparing Canadian Class II–IV submissions
• Knowledge of Canadian medical device regulations
• Strong organizational and communication skills
• Ability to multitask and meet deadlines

Preferred Qualifications

• Postgraduate certificate in Regulatory Affairs
• RAPS certification
• Experience with Investigational Testing Applications
• Experience in a cross-functional/global environment

Language Requirements

• English: Advanced (spoken and written)
• French: Basic functional

Additional Requirements

• Occasional travel (~5%)
• Flexible work schedule
• Advanced MS Office proficiency
• Experience with regulatory systems/databases