Regulatory Affairs Specialist (Mississauga) Job
Job Description Job Attributes+
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Job ID
31150645
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Req #
ABLAUS31150645ENUSEXTERNAL
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Job Location
Mississauga, ON, Canada
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Job Category
Regulatory Affairs
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Job Type
Full time
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Travel
Yes, 5 % of the Time
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Schedule
40 hours per week
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.
Job Skills
- regulatory submissions
- canadian medical device regulations
- regulatory compliance
- regulatory assessment
- product lifecycle support
- labeling compliance
- advertising compliance
- promotional materials compliance
- audit support
- regulatory databases
- ms office
- investigational testing applications
- stakeholder management
- deadline management
Additional Information
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.
