Ensure compliance with the Canadian Medical Devices Regulations SOR ∕98 – 242 and ensure on time submission of regulatory applications to Health Canada and maintain the licenses throughout the product lifecycle. Act as Regulatory Affairs subject matter expert and support commercial activities.
- Perform Regulatory Watch to identify new requirements, perform related impact assessments and to ensure timely escalation to Global RA.
- Perform change assessments (Lifecycle Management), prepare related Licence Amendments dossiers and submit them to Health Canada, as per defined timelines. Assist in the preparation of the Annual Medica Device Licence Renewal files.
- Prepare new product registration dossiers (class II and class III) and submit them to Health Canada, as per defined timelines. Coordinate and control regulatory processes to ensure timely execution aligned to product launch and business/registration plan.
- Assist in the development of answers to questions in the interactions/negotiations with Health Canada and stay current with Regulatory Affairs knowledge through Competent Authorities trainings, chambers, or other means.
- Perform Industry product specific RA activities (Industry specific RA assessments, Input for Health Canada Food Compendium Methods Licensing (MFHPB), maintenance and renewal of CFIA and PHAC permits).
- Provide feedback on the status of submissions and effectiveness of the regulatory processes (strategy, applications review with questions/answers, and problem resolution) and contribute to improvement plan. May work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment.
- Prepare Investigational Testing Authorization files and submit them to Health Canada.
- Support Sales Authorization process in SAP and tracking of licenses in the regulatory database.
- Assist in the execution and improvement of regulatory processes and interactions with regulatory agencies. Maintain and implement local RA procedures and ensure alignment with Global RA procedures.
- Participate in audit and inspection readiness activities of bioMérieux Canada (Health Canada inspections, MDSAP audits, Corporate Audits). Attend inspections and external RA related audits as required.
Studies and Experience:
- Bachelor’s degree in a Life or Biological Science; Master’s degree is an asset
- More than 5 years of experience in Regulatory Affairs in transnational companies in the area of in vitro diagnostics or medical devices
- Good knowledge of Health Canada organization and the Canadian Medical Devices Regulations including requirements, processes, and submission types
- Successful regulatory submissions experience including interactions with regulatory agencies
- Basic knowledge of Quality Management System requirements with developed knowledge of design and change controls
- IVD related technical knowledge
Skills and Qualifications:
- Strong communication skills, both written and verbal, in English and French is required
- Ability to analyse and use data to drive decisions; analyse and understand technical documents and regulatory requirements
- Knowledge of preparation of dossiers; technical writing skills to develop clear conclusions based on design documentation and to compile dossiers
- Routine problem solving, develop rationale, and propose solutions
- Independently identify compliance risks and escalate when necessary
- Excellent verbal and written communication skills with internal and external stakeholders
- Strong attention to detail and highly organized with the ability to manage multiple projects simultaneously
- Initiative / Ability to improve processes / Good interpersonal relationships / Work under pressure / Prioritization / Focus on driving results