Publié il y a 3 jours
Compliance Specialist II - Regulatory Affairs
@ Thermo Fisher Scientific
Ottawa, Ontario
En bref
Thermo Fisher Scientific is hiring a Compliance Specialist II for Regulatory Affairs to help ensure products and operations meet Canadian and international regulations. The role involves product onboarding assessments, maintaining regulatory licences and permits, monitoring regulatory change and supporting audits. Standard Monday to Friday office schedule; estimated pay in Ontario is $56,400 to $75,000 per year.
Responsabilités :
- Conduct regulatory assessments of new products for onboarding
- Maintain regulatory licences, permits and registrations
- Monitor regulatory changes and support implementation
- Support internal and external audits and government submissions
- Develop and maintain SOPs and regulatory documentation
Résumé des exigences :
- Bachelor's degree, preferably in life sciences or chemistry
- 2 to 5 years in regulatory, compliance or quality
- Knowledge of Health Canada medical device regulations
- Working knowledge of WHMIS, TDG, Precursor Chemicals and CGP
- Strong English communication; French preferred
Outils et compétences
Source et dates
Site carrière / système de candidatures · phenom
- Date publiée par l’employeur
- 2026-11-08
- Première détection par notre source
- 2026-11-02
- Mise à jour du dossier source
- 2026-11-10
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Intermédiaire |
| Domaine | Assurance qualité |
| Expérience | 2 an(s) et plus |
| Heures par semaine | 40 (estimé) |
| Horaire | jour |
| Déplacements | avion : aucun · route : aucun |
| Milieu de travail | Bureau |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English, French |
| Formation | Baccalauréat (exigé) |
| Domaines d’études | Life Sciences, Regulatory Affairs, Chemistry |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
Thermo Fisher Scientific
Profil d’entreprise sauvegardé
Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.
Description complète de l’entreprise
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
- Abonnés LinkedIn
- 2 209 029
- Personnes associées sur LinkedIn
- 99 378
- Bureaux déclarés
- 168 Third Avenue, Waltham, MA, US
- Catégories d’activité
- Electronics
- Health Care
- Consulting
- Cloud Data Services
- Advertising
- Manufacturing
- Bioinformatics
- Office Supplies
- Marketing
- Biotechnology
- Life Science
- Management Information Systems
- Precision Medicine
- Pharmaceutical
- Autres noms enregistrés
- Thermo Fisher Scientific
- Spécialités
- Analytical Instruments
- Laboratory Supply Chain Programs and eCommerce
- Laboratory Equipment
- Lab Services
- Specialty Diagnostics
- Life Sciences
- Pharma Services
- and CDMO
- Le profil indique une agence de recrutement
- Non
- Investissement total déclaré
- 19 766 434 812
La devise et la date d’observation ne sont pas fournies; ce n’est ni une valorisation actuelle ni une ronde de financement.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health…
| Champ | Valeur |
|---|---|
| Secteur | Biotechnology Research |
| Taille | 10,001+ employees |
| Siège social | Waltham, MA |
| Type d’organisation | Public Company |
| Spécialités | Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMO |
| Offres sur Jobsy | 54 |
| Voir la page |
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 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–$75,000.00.Journal
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