Director, Quality Assurance & Regulatory Affairs

  • Position: Director, Quality Assurance & Regulatory Affairs
    Reports to: Chief Executive Officer
    Location: Toronto
    Status: Permanent, Full-Time

    Role Summary:

    The successful candidate will be responsible for maintaining ISO 13485 Quality Management System to ensure suitability, adequacy and effectiveness in accordance with company’s objectives, quality manual, and procedures. They will ensure regulatory compliance and oversee the regulatory strategies for growth opportunities and product development in alignment with business priorities.

    Major Duties and Responsibilities

    1. Ensure compliance to ISO 13485 quality standards and applicable regulatory requirements pertaining to the IVD medical device industry (FDA, Health Canada, and foreign markets).
    2. Co-ordinate, prepare, review and implement new SOPs and ensure ongoing staff training.
    3. Work effectively with the R&D and manufacturing teams to develop process control/validation protocols.
    4. Assist management representative in the preparation for annual ISO quality system audit and external audits. Ensure audit responses are timely, complete and compliant.
    5. Lead and manage the eQMS implementation and maintenance.
    6. Provide leadership in the preparation and development of worldwide registration and approval activities for getting company’s product into the market.
    7. Develop regulatory strategies with respect to IVD device regulatory requirements, risk management, registration, and product safety testing standards.
    8. Perform regulatory due diligence, proactively identify business impact and opportunities in the regulatory environment.
    9. Lead and manage the preparation, compilation and assembly of submission documents to regulatory bodies including FDA and Health Canada.
    10. Identify major clinical, technical, or operational risks impacting on the success of regulatory filing, approvals, labeling and maintenance.
    11. Responsible for the development and maintenance of excellent working relationship with regulatory bodies and industry associations.

    Minimum Qualifications and Skills

    1. A minimum of 10 years of Quality Assurance & Regulatory Affairs with Quality Systems management experience within the medical device or pharmaceutical industry.
    2. Bachelor Degree in Science or related field, or experience demonstrating equivalent required knowledge and competencies.
    3. Certification in a regulatory or quality discipline preferred.
    4. Experience in ISO eQMS implementation and maintenance.
    5. In-depth understanding of emerging trends and issues in the changing regulatory landscape.
    6. Excellent and applied knowledge of FDA and Health Canada regulations for medical device industry IVD device.
    7. Experience with regulatory filings (510(k), Health Canada applications and international registrations).
    8. Travel may be required, when necessary.

    All applicants are welcome and appreciated, but only successful applicants will be contacts.