Regulatory Affairs Specialist (Mississauga)

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. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: CRLB Core Lab LOCATION: Canada > Mississauga : 6925 Century Avenue ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Not Applicable Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter