Compliance Specialist II - Regulatory Affairs

JOB DESCRIPTION

Work Schedule

Environmental Conditions

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 environment, making sure our food is safe or helping find cures for cancer.

ROLE REQUIREMENT: Onsite 5 days a week

DESCRIPTION:

• Conduct regulatory assessments of new products to support product onboarding using established internal screening procedures
• Review product inquiries and provide regulatory guidance to internal stakeholders, ensuring timely and compliant business decisions
• Ensure compliance with applicable Canadian and international regulations, including Transportation of Dangerous Goods (TDG), Canadian Standards Association (CSA), Medical Devices Regulations, and Natural Health Products Regulations
• Support customer order approvals involving regulated or restricted products in accordance with regulatory requirements and internal procedures
• Maintain 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 permits
• Monitor changes to regulatory requirements, assess business impacts, and support implementation of regulatory updates
• Partner with Distribution Centers, Customs Compliance, Supply Chain, Commercial, Quality, and other cross-functional teams to resolve regulatory issues and ensure business continuity
• Support internal and external audits and prepare regulatory reports, submissions, and documentation for government agencies
• Contribute to Regulatory Affairs projects, process improvements and system enhancements that improve compliance and operational efficiency

REQUIREMENTS:

• Bachelor's degree required, preferably in Life Sciences, Regulatory Affairs, Chemistry, or a related scientific discipline
• 3 to 5 years of experience in Regulatory Affairs, Compliance, Quality, or a related function, preferably within the medical device, pharmaceutical, life sciences industry
• Knowledge of Health Canada’s Medical Device regulatory requirements and related compliance programs
• Strong 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 detail
• Excellent written and verbal communication skills in English
• Proficiency in French language preferred
• Ability to manage multiple priorities, work independently, and collaborate effectively in a cross-functional environment
• Proficiency in Microsoft Office applications
• Experience participating in regulatory inspections, internal audits, and continuous improvement initiatives

Compensation