Regulatory Affairs & QA Specialist

• Evaluate all complaints classified as Potentially Reportable Events (PRE) and determine if Vigilance Reporting requirements apply within regulatory timelines. Complete applicable vigilance records and obtain approval.
• Prepare applicable Health Canada reports, obtain approval and submit reports to Health Canada as per applicable regulatory timelines.
• Prepare follow-up and final Health Canada reports, obtain approval and submit reports to Health Canada.
• Manage reporting of reportable events that occurred outside Canada as per applicable requirements of the Canadian Medical Devices Regulations.
• Ensure completion of adequate tools (Trackwise Digital, LLC…) to document each step of the process.
• Monitor and maintain familiarity with applicable regulations and assist with the review and revision of related local procedures.
• Assist in the execution and improvement of regulatory processes and interactions with regulatory agencies.
• Participate and support audits and inspections
• Work closely with local Customer Service to ensure a compliant process. Ensure regular meetings and related training.
• Assist in the completion of related local and Corporate QMS indicators and the definition and execution of action plans.
• Assist RQC US in the completion of Vigilance activities if needed.
• Assist with the management of FCA and FSCA.
• Assist with the Quality Management System as per activities assigned by the QA/RA Manager.

• Strong Knowledge of Canadian Medical Devices Regulations - MDR SOR ∕98 – 242
• Knowledge of the FDA 806 & 803
• Knowledge of QMS requirements

• Bachelor degree in Science, biology.
• 5 years of experience in the Medical Device Industry
• Knowledge of InVitro Diagnostic industry is an asset
• Strong computer skills Microsoft office (Word, Excel, Power point, outlook, Teams)
• Rigor, reliability, respect of timelines
• Strong analytical skills and ability to identify and propose solutions

Trackwise Digital