Manager, Regulatory Affairs

Stryker; Portage (MI); Híbrido; USD 127.000 - 211.000; Tempo integral

Benefícios oferecidos por esta vaga

Equal opportunity employer

Resumo da vaga

Stryker Corporation is seeking a Manager, Regulatory Affairs in Portage, Michigan. The role is hybrid with onsite collaboration at least three days per week and involves guiding global regulatory strategy across the product lifecycle.

You will lead regulatory processes, interact with authorities, and develop talent while partnering with R&D, Quality, Manufacturing, and Commercial teams to ensure compliant, timely product development and market access.

Qualificações

• Bachelor’s degree in a scientific/engineering discipline.
• Minimum 6 years in medical device/pharma industry.
• Experience with regulatory submissions and authority interactions.
• People management experience.

Responsabilidades

• Lead and develop a high-performing regulatory team with clear priorities and development plans.
• Translate evolving regulatory 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 regulatory negotiations with global authorities and external stakeholders.
• Oversee regulatory processes, issue evaluation and escalation.

Formação

Bachelor's degree in Engineering/Life Sciences/ Regulatory Affairs

Master’s degree in Engineering/Life Sciences/ Regulatory Affairs

Descrição da vaga

Work Flexibility: Hybrid 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 Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements.

Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.