Regulatory Analyst I

Job Description: The Regulatory Affairs representative serves as the designated responsible person for global product registration and regulatory compliance activities. This role leads registration, licensing, submission, and documentation activities while acting as the primary regulatory liaison to internal teams, regional representatives, and regulatory authorities to ensure continued market access throughout the product lifecycle.



Key Responsibilities

Product Registration & Approvals: Serve as the designated regulatory representative for product registrations, listings, licenses, notifications, and approvals, ensuring accurate and timely submission to regulatory authorities.



Regulatory Submissions: Prepare, coordinate, and compile European Union Technical Documentation, Canadian and other International Regulatory packages and supporting documentation to meet regional and global requirements.

Stakeholder Liaison: Act as the primary regulatory point of contact for internal and external stakeholders, providing guidance on regional registration requirements and communicating the regulatory impact of product changes. Ensure timely communication with stakeholders to meet regulatory requirements



Cross-Functional Coordination: Coordinate regulatory activities and communications to support submission timelines, project milestones, and alignment with stakeholders.



Documentation & Records Control: Create, review, update, and maintain regulatory documentation and records within approved document management systems in accordance with document control requirements, ensuring records remain accurate, current, and readily accessible for audits, inspections, and submissions.



Compliance & Market Access: Support continued commercialization by ensuring regulatory approvals and registrations are maintained in compliance with applicable regulations and quality system requirements.



Required Regulatory Knowledge

In Vitro Diagnostic Regulation (IVDR): Broad working knowledge of EU IVDR (Regulation (EU) 2017/746) requirements, including classification, conformity assessment, technical documentation, and registration obligations for in vitro diagnostic devices.



Canadian Regulations: Broad knowledge of Health Canada regulatory requirements, including the Medical Devices Regulations (SOR/98-282), medical device licensing (MDL), establishment licensing (MDEL), and applicable registration and listing requirements.



Global Regulatory Frameworks: Familiarity with applicable international regulatory requirements to support multi-region registration, licensing, and ongoing compliance activities.

Documentation Maintenance

Maintain regulatory records and documentation including submission files, registrations, licenses, approvals, and supporting records ensuring version control, timely revision to reflect product or registration changes, and retention in compliance with applicable document control procedures.





Ability to maintain confidentiality of information and materials