Director of Regulatory Affairs

Overview:
A leading global medical technology company is seeking a Director of Regulatory Affairs to lead pre-market regulatory strategy and execution for North America. This role is ideal for a seasoned regulatory professional with deep experience navigating FDA and Health Canada pathways, and a passion for shaping regulatory frameworks that support innovation and compliance.

The Director will oversee regulatory submissions and compliance for a diverse portfolio of medical technologies, including Class I-III devices. This individual will collaborate closely with global regulatory teams and cross-functional stakeholders to ensure timely approvals and successful market access in the U.S. and Canada. The role also includes team leadership, strategic planning, and direct engagement with regulatory authorities.

Key Responsibilities:

• Develop and implement regulatory strategies for U.S. and Canadian markets in collaboration with global regulatory teams.
• Lead the preparation and submission of regulatory filings, including Pre-Subs, 510(k)s, PMAs, IDEs, and Health Canada License Applications.
• Serve as the primary liaison with FDA and Health Canada, managing complex negotiations and regulatory interactions.
• Provide regulatory guidance to product development teams, ensuring alignment with regional requirements.
• Oversee regulatory review of product labeling, advertising, and promotional materials.
• Monitor evolving regulatory standards, guidance, and competitive intelligence to inform strategy and maintain compliance.
• Support import/export regulatory processes and ensure timely product releases.
• Participate in regulatory inspections and audits, ensuring readiness and compliance.
• Recruit, mentor, and manage a team of regulatory professionals to support North American operations.
• Communicate regulatory timelines, risks, and updates to senior leadership and cross-functional teams.
• Contribute to budget planning, process improvement, and internal training initiatives.

Qualifications:

• Bachelor's degree in a science or engineering discipline required; advanced degree preferred.
• 10+ years of regulatory, quality, or clinical experience in the medical technology industry.
• 5+ years of experience managing regulatory teams or operating in a global matrix environment.
• Proven experience with FDA and Health Canada submissions and inspections.
• Strong understanding of U.S. and Canadian regulatory frameworks for medical devices.
• Excellent communication, leadership, and organizational skills.
• Experience with both consumable and durable medical technologies is a plus.