Overview
Regulatory Affairs Specialist Jobs in Montreal, Canada at Amaris Consulting
Title: Regulatory Affairs Specialist
Company: Amaris Consulting
Location: Montreal, Canada
Category:
Location: Montreal
Job description
Join our team and embark on a new adventure in an international, dynamic, and highly regulated environment, where you can develop your career within a fast-growing organization.
Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in Regulatory Affairs, acting as a strategic partner to our clients, thanks to:
- Your leadership and communication skills, enabling you to build trusted relationships with internal and external stakeholders.
- Your critical and regulatory mindset, allowing you to anticipate risks and propose solutions aligned with current regulations.
- Your curiosity and continuous learning, supporting clients across multiple industries in complex regulatory environments.
Your Responsibilities
- Lead Regulatory Affairs activities for medical devices, ensuring compliance with European regulations (EU MDR – Regulation (EU) 2017/745).
- Act as an expert in medical device classification, with a focus on Class IIa and IIb devices, ensuring correct application of classification rules.
- Coordinate the preparation, review, and maintenance of technical documentation (Annexes II and III of the EU MDR).
- Provide expert support in CE Marking processes and conformity assessments, including direct interaction with Notified Bodies.
- Analyze and manage regulatory changes, assessing their impact on the product portfolio and defining regulatory strategies.
- Advise quality, clinical, R&D, manufacturing, and supply chain teams on regulatory matters throughout the device lifecycle.
- Lead responses to observations, questions, and non-conformities from health authorities and Notified Bodies.
- Ensure compliance with post-market requirements when applicable (PMS, PMCF, vigilance).
- Propose and lead improvements in regulatory processes, optimizing timelines, documentation quality, and compliance.
Your Profile
- 5+ years of experience in Regulatory Affairs for medical devices.
- Proven experience with European regulations (EU MDR).
- Strong expertise in Class IIa and IIb medical devices.
- Experience working with Notified Bodies and health authorities.
- Solid understanding of the regulatory lifecycle of medical devices (registration, maintenance, changes, and post-market).
- Academic background in Pharmaceutical Chemistry, Biomedical Engineering, Pharmacy, Health Sciences, or a related field.
- Advanced / fluent English (written and spoken).
- Strong analytical, decision-making, and prioritization skills.
- Leadership, autonomy, and stakeholder management skills in international environments.
Amaris Consulting promotes equal opportunities. We are committed to diversity and to creating an inclusive work environment. We welcome all qualified applicants regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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French Version
Rejoignez notre équipe et embarquez pour une nouvelle aventure dans un environnement international, dynamique et hautement réglementé, où vous pourrez développer votre carrière au sein d’une organisation en pleine croissance.
Être consultant chez Amaris Consulting, c’est vous positionner comme un référent technique et fonctionnel en Affaires Réglementaires, en agissant comme un partenaire stratégique pour nos clients, grâce à :
- Votre capacité de leadership et de communication, vous permettant de construire des relations de confiance avec les parties prenantes internes et externes.
- Votre vision critique et réglementaire, vous permettant d’anticiper les risques et de proposer des solutions alignées avec la réglementation en vigueur.
- Votre curiosité et votre apprentissage continu, en accompagnant des clients de multiples secteurs dans des environnements réglementaires complexes.
Vos missions
- Piloter les activités d’Affaires Réglementaires pour les dispositifs médicaux, en garantissant la conformité avec la réglementation européenne (EU MDR – Règlement (UE) 2017/745).
- Agir en tant qu’expert en classification des dispositifs médicaux, avec un focus sur les classes IIa et IIb, en assurant la bonne application des règles de classification.
- Coordonner la préparation, la révision et la maintenance de la…