Manager, Regulatory Affairs

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

Benefits offered by this job

Health benefits

401(k) plan

Stock Purchase Plan

Life insurance

Job summary

Stryker, Portage, Michigan, seeks a Manager, Regulatory Affairs for Surgical Technologies in a hybrid role based in Portage with three onsite days weekly. You will guide global regulatory strategy across the product lifecycle and partner with R&D, Clinical, Quality, Manufacturing, Marketing, and Commercial teams to integrate regulatory requirements into development plans.

This role leads regulatory processes, authority interactions, and team development in a complex global environment, balancing

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field.
• Minimum 6 years of experience in regulated industries (medical device/pharma/biotech).
• Experience preparing, reviewing, or overseeing regulatory submissions and authority interactions.
• People management experience or leading cross-functional programs.
• Experience with FDA, EU, and international regulatory requirements including ISO/Quality System standards.
• Fluency in English.

Responsibilities

• Lead, develop, and engage a high-performing regulatory team with clear priorities and development plans.
• Drive regulatory planning, translate evolving requirements into actionable market-access plans.
• Provide strategic regulatory guidance to R&D, Quality, Clinical, Manufacturing, and Commercial teams.
• Oversee regulatory submissions, registrations, agency interactions, inspections and audits.
• Lead interactions with global regulatory authorities, notified bodies, and industry groups.
• Monitor regulatory processes, escalate issues, and report metrics to identify risks and opportunities.
• Recruit, onboard, coach, and retain regulatory talent with accountability and development focus.
• Support regulatory advocacy, budgeting, forecasting, and strategic planning.
• Represent regulatory during audits and contribute to policy-shaping activities.

Skills

Regulatory leadership

Strategic planning

Cross-functional collaboration

People management

Regulatory submissions

FDA regulations

EU regulations

English fluent

Education

Bachelor’s in STEM

Master’s degree preferred

RAC certification

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

Required

What You Need

• 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

Health benefits include:

• Medical and prescription drug insurance
• dental insurance
• vision insurance
• critical illness insurance
• accident insurance
• hospital indemnity insurance
• personalized healthcare support
• wellbeing program and tobacco cessation program

Financial benefits include:

• Health Savings Account (HSA)
• Flexible Spending Accounts (FSAs)
• 401(k) plan
• Employee Stock Purchase Plan (ESPP)
• basic life and AD&D insurance
• short‑term disability insurance

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.