- 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