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Compliance Specialist II – Regulatory Affairs
Thermo Fisher Scientific —Ottawa, ON
- De 56 400 $ à 68 000 $ par an
- Temps plein
- Bilingue
- Anglais
- Microsoft Office
il y a 14 jours

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Compliance Specialist II – Regulatory Affairs

Thermo Fisher Scientific -
Ottawa, ON

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Détails du poste

Temps plein
De 56 400 $ à 68 000 $ par an
Il y a 14 jours

Profil recherché

Bilingue
Français
Anglais
Microsoft Office
Esprit d'analyse
Baccalauréat
Compétences en communication
Audit interne

Description complète du poste

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 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

The estimated annualized pay range for this position in Ontario is $56,400.00–$68,000.00.

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Compliance Specialist II – Regulatory Affairs

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