Spécialiste des affaires réglementaires (Montréal / Canada) / Regulatory Affairs Specialist (Montreal / Canada)

Abbott • Mississauga, ON

6d • Hybrid

About The Position

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of A company recognized as a great place to work worldwide and one of the most admired companies by Fortune A company committed to diversity, inclusion, and supporting women and professionals across all levels. This position is based in Canada (Montreal, Mississauga, Markham, Victoriaville or other locations) within the ADD division, with occasional travel requirements (~5% domestic and international). As a Regulatory Affairs Specialist, you will support regulatory activities to ensure compliance of medical devices with Canadian and international regulations. You will play a key role in preparing regulatory submissions, interpreting requirements, and collaborating cross-functionally to support product commercialization and lifecycle management. This role is ideal for someone detail-oriented, analytical, and comfortable working in a fast-paced, matrixed environment.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 1–3 years of relevant regulatory experience
• Knowledge of Canadian medical device regulations
• Experience preparing Class II–IV license applications
• Strong organizational, analytical, and communication skills
• Ability to manage multiple priorities in a fast-paced environment
• English: Advanced (spoken and written)
• French: Required

Nice To Haves

• Experience with Investigational Testing Applications
• Knowledge of Canada’s Food & Drugs Act
• Experience in a cross-functional or global organization
• Proficiency with MS Office and regulatory databases (e.g., Windchill, Zinc, PMMS)

Responsibilities

• Prepare high-quality regulatory submissions to meet business objectives
• Review and approve engineering change orders
• Analyze regulatory guidelines and support project regulatory assessments
• Maintain up-to-date knowledge of Canadian medical device regulations
• Interface with Health Canada when required
• Support product release processes and approvals
• Review protocols and reports supporting regulatory submissions
• Contribute to broader company initiatives
• Review communications for regulatory compliance
• Collaborate with cross-functional teams and external stakeholders
• Ensure clear communication across local and global teams
• Maintain accurate regulatory records and databases
• Ensure compliance with company policies, SOPs, and regulatory requirements

Benefits

• Career development with an international company where you can grow the career you dream of
• A company recognized as a great place to work worldwide and one of the most admired companies by Fortune
• A company committed to diversity, inclusion, and supporting women and professionals across all levels
• Flexible work schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level