Vigilance Analyst

Position Summary:

This position is responsible for the evaluation, coordination, preparation and execution of Regulatory and Quality Compliance policies, procedures and strategies regarding Vigilance Reporting.

Main Accountabilities:

• Evaluate all complaints classified as Potentially Reportable Events (PRE) Canada and determine if Incident Reporting (vigilance) requirements as per the Canadian Medical Devices Regulations (MDR SOR ∕98 – 282) apply within regulatory timelines.
• 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 as per applicable regulatory timelines.
• Manage reporting of reportable events that occurred outside Canada as per applicable requirements of the Canadian Medical Devices Regulations.
• Ensure Foreign Risk Notifications (FRN) management and reporting to Health Canada.
• Ensure Post-Market Summary Reports reporting to Health Canada, when applicable. Ensure input and liaison with Global Teams for Canada requirements for Post -Market Summary reports (bmx Inc, bmx SA and bioFire) to ensure compliance.
• Ensure adequate filing and archiving by using adequate tools to document each step of the different activities.
• Monitor and maintain familiarity with applicable regulations and perform 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.
• Act as a local Vigilance resource person.
• Work closely with local Customer Service to ensure a compliant process. Ensure regular meetings and related training.
• Monitor local and Corporate QMS indicators, define and drive execution of action plans.
• Contribute to the management of Field Corrective Actions and Field Safety Corrective Actions.
• Assist with various Regulatory Compliance activities
• Assist with the Quality Management System as per activities assigned by the QA/RC Manager

Studies and Experience:

• Requires a bachelor’s degree in science, Biology or Quality. A master’s degree is an asset.
• Requires 3 to 5 years related experience in the Medical Devices Industry (IVD industry is an asset).
• Requires knowledge of the Canadian Medical Devices Regulations, knowledge of FDA 806 & 803, knowledge of QMS requirements (ISO 13485, ISO 9001) and regulatory submission.
• Familiar in interactions with Health Canada.

Skills and Qualifications:

• Strong computer skills including Microsoft Office Package (Word, Excel, PowerPoint, Outlook, Teams). Trackwise Digital is an asset.
• Rigor, reliability, respect of timelines
• Good verbal, listening and writing communication skills.
• Proven collaboration and time management skills.
• Ability to work in an international environment.
• Be able to demonstrate a strong adaptability and a great sense of autonomy.
• Strong analytical skills and ability to identify and propose solutions.