Compliance Specialist II - Regulatory Affairs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our team to help enable our customers to make the world healthier, cleaner, and safer.

We are seeking a detail-oriented and proactive Compliance Specialist II – Regulatory Affairs to join our Regulatory Affairs team. In this role, you will help ensure our products and operations comply with applicable Canadian and international regulatory requirements. You will collaborate across multiple departments to support product onboarding, maintain regulatory licenses and permits, monitor evolving regulations, and drive continuous improvement initiatives that enable compliant business operations.

DESCRIPTION:

• Conduct regulatory assessments of new products using established screening procedures to support product onboarding.
• Review product inquiries and provide timely regulatory guidance to internal stakeholders to support compliant business decisions.
• Ensure compliance with applicable Canadian and international regulations, including Transportation of Dangerous Goods (TDG), WHMIS/OSHA, Canadian Standards Association (CSA) standards, the Medical Devices Regulations, and the Natural Health Products Regulations.
• Support customer order approvals for regulated or restricted products in accordance with regulatory requirements and internal procedures.
• Maintain regulatory permits, licences, and registrations, including Precursor Chemicals (Class A and B), the Controlled Goods Program (CGP), Medical Device Licences (MDLs), a Medical Device Establishment Licence (MDEL), and Canadian Food Inspection Agency (CFIA) import permits.
• Monitor regulatory changes, assess their business impact, and support implementation.
• Partner with Distribution Centers, Customs Compliance, Supply Chain, Commercial, Quality, and other cross-functional teams to resolve regulatory issues and support 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.
• Develop, maintain, and continuously improve Standard Operating Procedures (SOPs), work instructions, and regulatory documentation.

This is an excellent opportunity for an experienced regulatory professional who enjoys working in a fast-paced environment while balancing compliance, operational excellence, and customer support.

REQUIREMENTS:

• Bachelor's degree required, preferably in Life Sciences, Regulatory Affairs, Chemistry, or a related scientific discipline.

• 2 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

The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.