Manager, Regulatory Affairs

Stryker Group; Portage (MI); Hybrid; USD 127,000 - 211,000; Full time

Job summary

Stryker Group is seeking a Manager of Regulatory Affairs in Portage, Michigan for a hybrid role with onsite collaboration required at least three days per week. You will guide global regulatory strategy across the product lifecycle and partner with R&D, Quality, Manufacturing, and Commercial teams to ensure market access and compliant product development.

The role emphasizes leadership, strategic execution, and teamwork within a complex global regulatory environment, balancing planning and

Qualifications

• Bachelor’s degree required in engineering, life sciences, regulatory affairs, or related science discipline.
• Minimum 6 years in medical device, pharma, biotech or similarly regulated industry.
• Experience preparing or overseeing regulatory submissions and authority interactions.
• People management experience or leading cross-functional programs/projects.
• Experience with FDA, EU and international regulatory requirements including QS & ISO standards.
• Fluency in English.

Responsibilities

• Lead and develop a high-performing regulatory team with clear priorities and development plans.
• Translate evolving regulatory requirements into actionable plans for market access and cross-functional alignment.
• Provide strategic regulatory guidance to R&D, Quality, Clinical, Manufacturing and Commercial teams.
• Oversee regulatory submissions, registrations, agency interactions, inspections, and audits.
• Lead complex interactions with global regulatory authorities, notified bodies, and industry groups.
• Monitor regulatory metrics and report risks and improvement opportunities.
• Recruit, onboard, coach, and retain regulatory talent while promoting accountability and growth.
• Support budgeting, forecasting, and strategic planning for regulatory activities.
• Represent the regulatory function during audits and contribute to policy-shaping activities.

Skills

Regulatory leadership

Cross-functional collaboration

People management

Regulatory strategy

English proficiency

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field

Job description

Stryker is seeking a Manager, Regulatory Affairs to support our Surgical Technologies business. This hybrid role is based in Portage, Michigan, with an expectation of onsite collaboration a minimum of three days per week.

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.

• USN: $126,500 - $210,700 USD Annual