Compliance Specialist Ii – Regulatory Affairs (Gatineau)

Compliance Specialist Ii – Regulatory Affairs (Gatineau)

31 Aug
|
Thermo Fisher Scientific
|
Gatineau

31 Aug

Thermo Fisher Scientific

Gatineau

**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Office**Job Description**As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the setting, making sure our food is safe or helping find cures for cancer.ROLE REQUIREMENT: Onsite 5 days a weekDESCRIPTION:Conduct regulatory assessments of new products to support product onboarding using established internal screening proceduresReview product inquiries and provide regulatory guidance to internal stakeholders, ensuring timely and compliant business decisionsEnsure compliance with applicable Canadian and international regulations, including Transportation of Dangerous Goods (TDG), Canadian Standards Association (CSA), Medical Devices Regulations, and Natural Health Products RegulationsSupport customer order approvals involving regulated or restricted products in accordance with regulatory requirements and internal proceduresMaintain regulatory permits, licenses, and registrations, including Precursor Chemicals (Class A & B), Controlled Goods Program (CGP), Medical Device Licences (MDLs), Medical Device Establishment Licence (MDEL), and Canadian Food Inspection Agency (CFIA) import permitsMonitor changes to regulatory requirements, assess business impacts, and support implementation of regulatory updatesPartner with Distribution Centers, Customs Compliance, Supply Chain, Commercial, Quality,



and other cross-functional teams to resolve regulatory issues and ensure business continuitySupport internal and external audits and prepare regulatory reports, submissions, and documentation for government agenciesContribute to Regulatory Affairs projects, process improvements and system enhancements that improve compliance and operational efficiencyREQUIREMENTS:Bachelor's degree required, preferably in Life Sciences, Regulatory Affairs, Chemistry, or a related scientific discipline3 to 5 years of experience in Regulatory Affairs, Compliance, Quality, or a related function, preferably within the medical device, pharmaceutical, life sciences industryKnowledge of Health Canada's Medical Device regulatory requirements and related compliance programsStrong working knowledge of the Canadian chemical compliance framework, including the WHMIS, Transportation of Dangerous Goods (TDG), Precursor Chemicals, and the Controlled Goods Program (CGP) regulations. Direct experience with these regulations is considered an asset.Experience maintaining regulatory licenses, permits, registrations, and compliance documentation.Strong analytical, organizational, and problem-solving skills with exceptional attention to detailExcellent written and verbal communication skills in EnglishProficiency in French language preferredAbility to manage multiple priorities, work independently, and collaborate effectively in a cross-functional environmentProficiency in Microsoft Office applicationsExperience participating in regulatory inspections, internal audits, and continuous improvement initiatives**Compensation**The estimated annualized pay range for this position in Ontario is $56,400.00–$68,000.00.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

📌 Compliance Specialist Ii – Regulatory Affairs (Gatineau)
🏢 Thermo Fisher Scientific
📍 Gatineau

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