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Abbott
Regulatory Affairs Specialist (Mississauga)Abbott • Mississauga, Ontario, Canada
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Regulatory Affairs Specialist (Mississauga)

Regulatory Affairs Specialist (Mississauga)

Abbott • Mississauga, Ontario, Canada
30+ days ago
Salary
CA$250.00 daily
Job type
  • Full-time
Job description

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
Compensation:68, 250 $ - 100,100 $
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Regulatory Affairs Specialist (Mississauga) • Mississauga, Ontario, Canada

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