Sr. Regulatory Affairs Manager

Position Summary:

Ensure compliance with the Canadian Medical Devices Regulations SOR ∕ 98 – 242, guidance documents, and standards recognized by Health Canada. Ensure on time submission of regulatory applications to Health Canada and effective maintenance of licenses throughout the product lifecycle for in vitro diagnostics and medical devices. 

Main Accountabilities:

• Be the regulatory correspondent of bioMérieux Canada for Health Canada.  Ensure compliance and demonstrate the safety and efficacy of IVD, RUO, GLU, and industry products with local health authority regulations, guidance documents, and standards.
• Develop, drive, and implement local regulatory strategy, ensuring that it is crafted to deliver rapid approval. Communicate potential risks and mitigations associated with regulatory strategies to stakeholders. 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. Develop strategic and tactical responses and negotiate to influence a reasonable regulatory environment.
• Manage and submit new product license applications to Health Canada, as per defined timelines. Coordinate and control regulatory processes to ensure timely execution aligned to product launch and business/ registration plan. Answer Health Canada’s questions or requests for additional information.
• Manage the Lifecycle Management process and change impact assessments for Canada. Prepare related license amendments and submit them to Health Canada, as per defined timelines. Provide answers to questions from Health Canada. Manage and submit annual license renewal.
• Perform efficient Regulatory Watch to identify new requirements, perform related impact assessments, and to ensure timely escalation to Global RA. Participate in industry associations as bioMérieux’s regulatory representative. Stay current with Regulatory Affairs knowledge through Competent Authorities trainings, chambers, or other means.
• Support and attend audits / inspections and manage inspection readiness activities for MDSAP, Health Authorities, and Corporate Audits. Contribute to improvement plan.
• Analyze and drive RA process efficiency. Assist in the execution and improvement of regulatory processes and interactions with regulatory agencies. Maintain local RA procedures.
• Manage and develop regulatory affairs employee(s) carrying out product registration and change activities. Manage individual and collective performance in the department, including training and development. Optimize resources and manage the budget process.

Studies and Experience:

• Bachelor’s degree or equivalent. Science background is preferred. Advanced secondary degree is a plus. Strong working knowledge of local health authority regulations and requirements.
• 6+ years in regulatory affairs or equivalent, medical device/IVD industry preferred, including 1+ years leading projects and directly managing other employees and teams.
• Independent and successful regulatory submissions experience. Direct interface with regulatory authorities.
• Strong knowledge of regulatory requirements and Quality Management System, including design and change controls.
• MDSAP experience

Skills and Qualifications:

• Strong written and oral communications skills. Influence, challenge, and negotiate with internal/external stakeholders, including regulatory agencies
• Leadership, analytical, results oriented, and problem-solving
• Ability to analyze and understand technical and scientific documents to develop clear conclusions and to compile dossiers.
• Demonstrate initiative and can work both independently and collaboratively in a team structure. Ability to work well within a multicultural team environment.