About the role
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.
About bioMérieux
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors.
In 2020, revenues reached €3.1 billion, with over 90% of sales outside of France.
bioMérieux provides diagnostic solutions (systems, reagents, software, services) which determine the source of disease and contamination to improve patient health and ensure consumer safety.
Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the Euronext Paris stock market.
Symbol: BIM – ISIN Code: FR0013280286 Reuters: BIOX.PA/Bloomberg: BIM.FP
About the role
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.
About bioMérieux
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors.
In 2020, revenues reached €3.1 billion, with over 90% of sales outside of France.
bioMérieux provides diagnostic solutions (systems, reagents, software, services) which determine the source of disease and contamination to improve patient health and ensure consumer safety.
Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the Euronext Paris stock market.
Symbol: BIM – ISIN Code: FR0013280286 Reuters: BIOX.PA/Bloomberg: BIM.FP