Regulatory Affairs Specialist at Prollenium Medical Technologies Inc. in Richmond Hill, Ontario

Job description

• 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.

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.

Requirements

• 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.
• 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.

Skills

Required

• Strong attention to detail
• Technical writing
• Organization
• Ability to manage multiple priorities

Preferred

• Knowledge of ISO 13485
• FDA Quality System requirements
• Equipment qualification/validation
• Change control

Benefits

• $60000 - $70000