guelph, on regulatory affairs specialist Jobs – 1 Openings This Week

Regulatory Affairs Specialist (Mississauga)
Abbott Laboratories —Mississauga, ON
- $68,250–$100,100 a year
- Full-time
- Engineering
- English
- Microsoft Office
- Flexible schedule

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Regulatory Affairs Specialist (Mississauga)
Abbott Laboratories —Mississauga, ON
Prepare and submit annual license renewals (medical device and establishment licenses). Bachelor’s degree in Life Sciences, Engineering, or related field.
$68,250–$100,100 a year
Regulatory Affairs Specialist - Instructor & Consulting Support
AAPS —Toronto, ON
Assist in developing or develop SOPs, quality documentation, and corrective/preventive action plans (CAPAs). Lead or Assist in with the preparation, review, and…
$75,000–$90,000 a year
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Regulatory Affairs Specialist (Mississauga)

Abbott Laboratories
Mississauga, ON

Apply Now

Job details

Full-time

Benefits

Flexible schedule

Skills

French
Engineering
English
Microsoft Office
Databases
Bachelor's
Communication skills

Full job description

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.

Apply Now

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