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 AbbottAt 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 ofA company recognized as a great place to work worldwide and one of the most admired companies by FortuneA company committed to diversity, inclusion, and supporting women and professionals across all levelsThe OpportunityThis 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 workplace.What You’ll DoRegulatory SubmissionsCoordinate and prepare regulatory submissions for diagnostic and distributed productsRespond to Health Canada requests for additional informationPrepare and submit annual license renewals (medical device and establishment licenses)Compliance & Regulatory AssessmentConduct regulatory assessments for product changesSupport Summary Report activitiesAssess impact of emerging regulationsEnsure labeling, advertising, and promotional materials comply with regulationsProduct Support & AuditsSupport product release processes and approvalsReview protocols and reports for regulatory activitiesSupport internal and external auditsCollaboration & OperationsMaintain regulatory submission databases and trackersInterface with Health Canada when requiredCollaborate with internal teams and external stakeholdersMaintain effective and professional communicationAdditional ResponsibilitiesSupport company initiativesEnsure compliance with regulations, SOPs, and policiesPerform other duties as assignedRequired QualificationsBachelor’s degree in Life Sciences, Engineering, or related field1–3 years of relevant regulatory experienceExperience preparing Canadian Class II–IV submissionsKnowledge of Canadian medical device regulationsStrong organizational and communication skillsAbility to multitask and meet deadlinesPreferred QualificationsPostgraduate certificate in Regulatory AffairsRAPS certificationExperience with Investigational Testing ApplicationsExperience in a cross-functional/global environmentLanguage RequirementsEnglish: Advanced (spoken and written)French: Basic functionalAdditional RequirementsOccasional travel (~5%)Flexible work scheduleAdvanced MS Office proficiencyExperience with regulatory systems/databasesCompensation68,250 $ - 100,100 $Equal Opportunity EmployerAbbott is an Equal Opportunity Employer committed to diversity.#J-18808-Ljbffr

📌 Regulatory Affairs Specialist (Mississauga) - C$68,250 - C$100,100 A Year (Winnipeg)
🏢 Abbott
📍 Winnipeg