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) As a Senior Manager, Regulatory Affairs on Stryker's Joint Replacement market access team, you will provide leadership and guidance to integrate regulatory considerations into global product continuity and exit strategy. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones and cultures to achieve market access in alignment with global regulatory requirements. To learn more about Stryker's Joint Replacement portfolio click here: Joint replacement | Stryker (https://www.stryker.com/us/en/portfolios/orthopaedics/joint-replacement.html) You will need to live within commuting distance to our Mahwah, New Jersey office. You will need to be in the office 2 days a week. **What you will do** + Provide guidance to integrate regulatory considerations into global product maintenance and exit strategies. + Evaluate changing regulations, their implications on renewal and post-approval strategies, and develop solutions for market access challenges. + Collaborate effectively cross-functionally and provide strategic input and technical guidance on global regulatory requirements. + Ensure that submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission. + Lead interactions with regulatory authorities, manage complex negotiations, and participate in advocacy initiatives on a global scale. + Represent regulatory processes during internal and external audits. + Establish KPIs, manage regulatory metrics, and optimize resource allocation for efficient project execution. + Recruit, develop, and retain a high-performing team, fostering engagement and addressing performance issues effectively. **What you need** **Required Qualifications:** + Bachelor's degree in science, engineering or related field + Minimum of 10 years’ experience + Demonstrated leadership, management, and process improvement skills + Demonstrated ability to develop direct reports and encourage healthy team dynamic **Preferred Qualifications:** + Minimum of 12 years’ experience + Master's Degree or equivalent + RAC desired + 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 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.