Regulatory Affairs Specialist

Company Overview:

Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium hyaluronic acid (HA) dermal fillers and cosmetic products. We are proud to address all of our client's needs through streamlined innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of new and exciting products that provide safe and effective results. With regulatory approvals from the US FDA and Health Canada, Prollenium has sold over 5 million syringes from its Revanesse® product line across more than 80+ countries worldwide. Prollenium was the first manufacturer of hyaluronic acid dermal fillers in North America. Join our dedication to innovation. Prollenium provides competitive compensation, benefits, and development opportunities.

Job Summary

The Regulatory Affairs Specialist will be responsible for managing regulatory affairs projects, applications, and submissions for Prollenium’s Class I-III medical devices as well as supporting other mandates with cosmetic products. This position reports to the Chief Regulatory, Clinical and Medical Affairs Officer. The Specialist will work cross-functionally to ensure medical devices, equipment, and associated documentation meet applicable regulatory requirements and timelines.

Major Responsibilities

• Prepare, review, and maintain technical and regulatory documentation for medical devices and equipment.
• Maintain technical files, device/equipment specifications, drawings, test reports, risk documentation, labelling, and Instructions for Use (IFUs).
• Review equipment and product changes for regulatory impact and required documentation.
• Support documentation for equipment qualification, verification, validation, and performance testing.
• Support regulatory submissions, registrations, licenses, amendments, and renewals for Health Canada, US FDA, EU, and other applicable authorities.
• Coordinate regulatory documentation from equipment manufacturers, suppliers, and contract manufacturers.
• Support change controls, deviations, CAPAs, and non-conformances with regulatory impact.
• Assist with Technical Files, Design Dossiers, PMCF documentation, PSURs, and other regulatory records, as applicable.
• Support regulatory audits and inspections and ensure requested documentation is accurate and readily available.
• Prepare and support ARTG applications.
• Support external audit preparation, including Microbiology, MDSAP, FDA, and CE audits.
• Provide regulatory inputs for Management Review.
• Support applicable quality, microbiology and other types of audits as needed and support the resolution of non-conformances.

Minimum Qualifications

• Bachelor’s degree in Biomedical Engineering, Life Sciences, or a related discipline.
• Minimum 2–4 years of Regulatory Affairs experience within the medical device industry; medical device experience is essential.
• Experience preparing and maintaining technical and regulatory documentation for medical devices and/or equipment.
• Working knowledge of Health Canada, US FDA and EU medical device requirements.
• Experience with technical files, equipment documentation, specifications, validation/testing documentation, risk documentation, labelling, and IFUs.
• Strong attention to detail, technical writing, organization, and ability to manage multiple priorities.

Preferred Qualifications

• Experience supporting Class II and/or Class III medical devices and medical device equipment.
• Knowledge of ISO 13485, FDA Quality System requirements, equipment qualification/validation, and change control.
• Experience supporting FDA, Health Canada, MDSAP, CE/EU audits or regulatory submissions.

Key Competencies

• Attention to detail and documentation accuracy.
• Technical and regulatory writing.
• Organization and problem-solvin
• Ability to work cross-functionally in a regulated environment.
• Ability to manage different projects in parallel.
• Team player, within the Regulatory Team but also with other functions and departments.

The position is based in Richmond Hill and follows a hybrid work model, with 4 days in the office and 1 day working from home.

Note: We use AI-enabled tools to support certain aspects of our recruitment process.