Regulatory Affairs Job at Abbott, Canada | Life Sciences | Earn $100,100 CAD | Apply Now
If you are a regulatory professional with a strong foundation in medical device compliance, looking to elevate your career with a global healthcare leader, this full-time position at Abbott is an exceptional opportunity. Located at the regional corporate hub in Mississauga, Ontario, this role sits within the high-growth Abbott Diagnostics Division (ADD). For detail-oriented compliance analysts searching for a high-trajectory Regulatory Affairs Job, this position offers a structured, fast-paced environment to master Health Canada Class II–IV submissions and product lifecycle management. It serves as an elite launchpad for a long-term Abbott career and stands out as a premier Life Sciences Job in Canada within the medical technology sector.
- Job Position: Regulatory Affairs Specialist (Mississauga)
- Location: Canada – Ontario – Mississauga
- Category:Â Regulatory Affairs
About The Company
Abbott is a globally recognized healthcare pioneer dedicated to creating breakthrough science and advanced technology to improve human health. Recognized worldwide as a Great Place to Work and celebrated by Fortune as one of the world’s most admired companies, Abbott operates at the leading edge of medical diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals. The Abbott Diagnostics Division (ADD) provides laboratories and hospitals in Canada and across the globe with automated instrumentation and molecular assays that enable faster, more accurate clinical decision-making.
Regulatory Affairs Job – Key Responsibilities
As a Regulatory Affairs Specialist, you will ensure that Abbott’s innovative diagnostic products remain fully compliant with Health Canada regulations throughout their entire lifecycle.
Your core submission, compliance, and operational duties will include:
- Health Canada Submissions: Coordinating, drafting, and preparing high-quality regulatory submissions for Class II, III, and IV diagnostic devices and distributed products.
- Agency Liaison: Acting as a point of contact for Health Canada, managing official requests for additional information (AI), and preparing annual medical device and establishment license renewals.
- Regulatory Change Assessments: Conducting rigorous regulatory assessments for proposed product modifications, software updates, or manufacturing alterations to determine required filings.
- Promotional Review: Auditing product labeling, instructions for use (IFU), advertising campaigns, and commercial promotional materials to verify total alignment with Canadian legal parameters.
- Audit & Quality Support: Reviewing clinical protocols and validation reports, supporting product release workflows, and assisting with internal and external quality system audits.
- Database Operations: Maintaining and updating internal regulatory submission trackers, archiving files, and distilling emerging Canadian regulations into actionable insights for global stakeholders.
Qualifications & Profile Requirements For Regulatory Affairs Job
This intermediate compliance role is tailored for precise professionals who possess a strong command of Canadian medical device classification systems.
- Educational Foundation: A Bachelor’s degree in Life Sciences, Engineering, or a related quantitative scientific field is mandatory for this Life Sciences Job in Canada.
- Experience Range: 1–3 years of relevant regulatory affairs experience within the medical device or pharmaceutical industry.
- Submission Track Record: Proven, hands-on experience preparing and submitting Health Canada Class II–IV medical device licenses.
- Regulatory Acumen: Solid, practical knowledge of the Canadian Medical Devices Regulations (CMDR) and associated Health Canada guidance documents.
- Linguistic Skills: Advanced proficiency in English (written and verbal) is required; basic functional knowledge of French is required to navigate regional Canadian labeling demands.
- Preferred Assets:
- A postgraduate certificate in Regulatory Affairs or an active Regulatory Affairs Certification (RAC) via RAPS.
- Direct experience handling Investigational Testing Applications (ITAs) for clinical trials.
- Prior experience operating within a highly matrixed, global cross-functional corporate environment.
- Advanced proficiency in MS Office tools and deep familiarity with corporate regulatory database architectures.
Compensation, Logistics & Benefits
Abbott is committed to providing an inclusive, diverse environment that rewards high performance and supports personal well-being:
- Base Salary Range: $68,250 – $100,100 CAD annually (Final compensation is determined by factors including your specific submission experience, technical knowledge, and skill set).
- Location: Mississauga, Ontario, Canada. This is an office-based position within the diagnostics division.
- Travel Requirements: Occasional domestic and international travel (~5%) for corporate meetings or agency briefings.
- Abbott Perks: Access to world-class career development paths, comprehensive health and wellness options, retirement savings plans, and dedicated support for professionals at all levels.
In short, the Regulatory Affairs Specialist position at Abbott Diagnostics is a definitive route to transitioning your foundational compliance background into a high-visibility, global regulatory asset. Securing this role allows you to step away from basic laboratory documentation and take primary control of complex regulatory filings that dictate whether next-generation diagnostic tools enter the Canadian healthcare market. If you live in the Greater Toronto Area, possess a proven track record with Health Canada submissions, and are ready to excel within a matrixed leader, apply today to lock in this premier Regulatory Affairs Job.
