Regulatory Affairs Manager

  • Regulatory Affairs Manager
    Montreal or Quebec City, Quebec
    Our client, a medical device company specializing in the production of various medical equipment and healthcare products, is in search of a Pre-Market Regulatory Affairs Manager. The incumbent will deliver the regulatory strategy and regulatory plans throughout the design and development process of new products. Working closely with North American and European health authorities as well as internal stakeholders, you will ensure strong work relationships critical to the organizations' success.
    Key Responsibilities
    • Develop and execute the pre-market regulatory strategy and tactical plans.
    • Assist marketing and commercial teams to identify product portfolio gaps/opportunities, support product positioning.
    • Support regulatory assessment of future product offering opportunities during Merger and Acquisition process
    • Organize project activities and deliverables.
    • Lead the implementation of process improvements/tools.
    • Support the smooth knowledge transfer and transition of new products to the Post-Market Regulatory Compliance team.
    • Ensure your team’s deliverables are met timely with accuracy.
    • Coach, mentor and develop team members.
    • Bachelor’s degree in engineering, life sciences, quality/regulatory or related technical discipline.
    • Minimum of 8 years progressive experience in Regulatory Affairs environment, preferably in medical devices.
    • Minimum of 5 years of experience in management of personnel and enabling a positive company culture.
    • Strong experience and demonstrated success in dealing with regulatory agencies (Canada, US, Europe) for regulatory approvals of new and innovative products.
    • Knowledge of regulatory requirements for medical devices (primary focus), natural health products and drug products (Canada, US and Europe).
    • Bilingualism (French and English) required
    • Strong communication skills with the ability to interact and influence,
    • Solid business acumen.
    • Demonstrated flexibility and creativity with a solutions-oriented approach.
    Thank you in advance for your interest, only individuals deemed to have the skill set and experience to fit the role will be contacted.
    Lock Search Group is a National Executive Recruitment firm with 11 offices in Canada and one in the United States, a staff of more than 30 Consultants and Associates, and expertise in 11 major disciplines. Our mission is to provide exceptional Recruitment and Consulting Services to clients and candidates. We apply our experience and expertise to deliver solutions with a personalized approach that focuses on client needs and candidate goals.
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