We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at  www.stryker.com We are currently seeking a **Manager, Regulatory Affairs** to join our **Instruments** **Division** . This is a hybrid role based in **Portage, Michigan** **.** The Manager, Regulatory Affairs is responsible for developing regulatory strategy in the Instruments Division to enable and maintain market access in the United States, Canada, Europe and global regions. Through close partnership with business unit, Marketing, R&D, Clinical, Quality, production and supply teams, the Manager will lead a team who develops and advises on product positioning, product maintenance and exit strategies, among others. **What you will do** + Develops and updates US, global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies + Provides guidance to integrate regulatory considerations into global product entry, maintenance and exit strategies + Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures + Provides strategic input and technical guidance on global regulatory requirements to cross-functional teams + Provides guidance on regulatory strategies and submissions addressing business, marketing, design, labeling, supply and manufacturing changes + Ensure that submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission + Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions + Represent regulatory processes during internal and external audits + Participate in internal & external advocacy activities of a strategic nature + Recruit, select, and on-board top talent + Develop talent within team to increase performance. Actively address performance issues on team + Maintain a high level of team engagement + Manage and provide updates for regulatory metrics. Implement appropriate enhancements + Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets **What you need** + Bachelors in a science, engineering or related Advanced degree. + Minimum of 9 years’ experience required + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements + Demonstrate technical knowledge of medical device product lines + Demonstrated written, verbal, listening, communication, and team-building skills + Demonstrated ability to collaborate effectively with and lead cross-functional teams + Demonstrated ability to effectively prioritize and manage multiple project workloads + Demonstrated experience with trending and analysis reporting **Preferred** + Master's Degree or equivalent + RAC desired 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, and 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. 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.