Stryker is seeking a **Manager, Regulatory Affairs** to join our **Emergency Care** division to be based onsite Monday through Wednesday in Redmond, WA (remote Thursday and Friday). **What you will do** As the **Manager, Regulatory Affairs** you will be responsible for providing leadership, organization and coordination of Stryker Medical Redmond’s global regulatory strategies, registrations and submissions to support ongoing global market operations and also support high impact product launches. This covers product portfolios within our Emergency Care Transport business unit. + Establish a regulatory center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvement in regulatory processes. Oversee consistency of regulatory processes. + Drive new approaches to improve the development, review, and oversight of healthcare products. + Direct and contribute to initiatives within the organization, with groups engaged in the development of good regulatory practice and policy. + Establish annual budgets and quarterly forecasts + Make necessary changes with appropriate management involvement + Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met + Serve as Subject Matter Expert for regulatory processes + Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations + Establish standard process to ensure appropriate resolution and management of the responsible task owner + Chair meetings required to drive closure of regulatory issues + Manage and provide updates for regulatory metrics + Implement appropriate enhancements + Represent regulatory processes during internal and external audits + Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets + 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 + Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature **What you need** + Bachelor’s Degree required; preferably in Science or Engineering. + A minimum of 8 years of experience within a regulated industry required; preferably in Medical Device. + A minimum of 4 years of Medical Device Quality or Regulatory Affairs experience required. **Preferred** + Supervisory experience + A Master’s Degree or advanced degree + RAC Certification + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements required + Demonstrated technical knowledge of medical device product line required + $132,900.00 - 217,500.00 USD,salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. 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.