Regulatory Affairs Specialist at Abbott

About Abbott

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

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 $

Follow your career aspirations to Abbott

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to diversity.

Connect with us at www.abbott.com and on social media @AbbottNews and @AbbottGlobal.