Manager, Regulatory Affairs

About the role

Stryker is seeking a Manager, Regulatory Affairs to support its Surgical Technologies business. This hybrid role is based in Portage, Michigan, with an expectation of onsite collaboration at least three days per week. The manager guides global regulatory strategy across the product lifecycle and partners with Product Development, Clinical, Quality, Manufacturing, Marketing and Commercial teams so that regulatory requirements are integrated into business decisions, market access strategies and product development plans.

Key responsibilities

• Lead, develop and engage a team of regulatory professionals through priorities, performance objectives, development plans and operating practices.
• Translate evolving regulatory requirements into actionable plans that enable market access and inform cross-functional plans.
• Provide strategic regulatory guidance to R&D, Quality, Clinical & Medical Affairs, Manufacturing and Commercial teams.
• Oversee regulatory submissions, registrations, agency interactions, inspections and audits, and lead complex negotiations with regulatory authorities, notified bodies, industry associations and other stakeholders.
• Monitor and report regulatory metrics to identify risks, improvement opportunities and resource needs.
• Recruit, onboard, coach and retain talent, and support advocacy, process improvement, budgeting, forecasting and strategic planning.
• Represent the regulatory function in internal and external audits and contribute to regulatory advocacy and policy work.

Required profile

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs or a related scientific discipline.
• Minimum 6 years of experience in the medical device, pharmaceutical, biotechnology or other highly regulated industries.
• Experience preparing, reviewing or overseeing regulatory submissions and regulatory authority interactions.
• People management experience or experience leading critical cross-functional programs or projects.
• Fluency in English.
• Preferred: Master's degree, Regulatory Affairs Certification (RAC), and experience managing teams, budgets and organizational development.

Required skills

• Experience with FDA, European Union and international regulatory requirements, including Quality System and ISO standards.
• Experience developing and executing regulatory strategies across the product lifecycle.

What we offer

• Salary range of $126,500 - $210,700 USD annually.
• Hybrid work arrangement with up to 20% travel.