Manager, Regulatory Affairs

As the Manager, Regulatory Affairs, you will guide global regulatory strategy across the product lifecycle. This position serves as a key partner to Product Development, Clinical, Quality, Manufacturing, Marketing, and Commercial teams, ensuring regulatory requirements are integrated into business decisions, market access strategies, and product development plans. In addition to providing technical and strategic regulatory expertise, this role leads regulatory processes, regulatory authority interactions, and team development activities that support global business objectives.

This role is ideal for an experienced regulatory affairs leader who enjoys balancing strategic planning, regulatory execution, cross-functional leadership, and team development within a complex global regulatory environment.

What You Will Do

• Lead, develop, and engage a high-performing team of regulatory professionals by establishing clear priorities, performance objectives, development plans, and effective regulatory operating practices.
• Lead teams in regulatory planning activities, translating new & evolving regulatory requirements into actionable plans that enable market access and inform cross-functional plans to mitigate potential obstacles.
• Provide strategic regulatory guidance to R&D, Quality, Clinical & Medical Affairs, Manufacturing & Commercial teams to enable compliant and efficient product development and align regulatory strategies with organizational goals.
• Oversee regulatory submissions, registrations, agency interactions, inspections, and audit activities, ensuring organizational readiness and timely resolution of questions or observations.
• Lead complex interactions and negotiations with global regulatory authorities, notified bodies, industry associations, advocacy groups, and other external stakeholders.
• Oversee regulatory processes and ensure issues are appropriately evaluated, assigned, escalated, and resolved.
• Monitor, and report regulatory metrics to identify risks, improvement opportunities, and resource needs.
• Recruit, onboard, coach, and retain high-performing talent while promoting accountability, engagement, and continuous development.
• Support regulatory advocacy, process improvement, budgeting, forecasting, and strategic planning activities.
• Represent the regulatory function during internal and external audits and contribute to regulatory advocacy and policy-shaping activities that advance organizational and industry objectives

What You Need

Required

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific discipline.
• Minimum 6 years of experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industry.
• Experience preparing, reviewing, or overseeing regulatory submissions and regulatory authority interactions.
• People management experience or demonstrated experience leading critical cross-functional programs or projects.
• Experience with FDA, European Union, and international regulatory requirements including Quality System & ISO standard requirements.
• Fluency in English.

Preferred

• Master's degree in Engineering, Life Sciences, Regulatory Affairs, Business, or a related field.
• Regulatory Affairs Certification (RAC).
• Experience managing teams, performance objectives, budgets, and organizational development initiatives.
• Experience developing and executing regulatory strategies across the product lifecycle.