Stryker is seeking an Associate Manager, Regulatory Affairs, to support Emergency Care! You will provide leadership, direction, and coordination for Stryker Medical Redmond’s global regulatory strategies, registrations, and submissions - supporting both ongoing global market operations and high-impact product launches. You’ll oversee regulatory activities for product portfolios within our Emergency Care Transport business unit!
Workplace Flexibility: Hybrid role based in Redmond, WA. Onsite Monday through Wednesday, with remote work on Thursday and Friday.
What You Will Do:
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.
Lead and contribute to regulatory initiatives, including the development of good regulatory practices, policies, and advocacy activities.
Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
Oversee daily regulatory operations to ensure effective issue evaluation and resolution, serving as the subject matter expert and chairing key meetings to drive closure of regulatory issues.
Provide strategic guidance and implementation plans for compliance with evolving regulatory requirements.
Establish standard process to ensure appropriate resolution and management of the responsible task owner.
Develop and manage budgets, quarterly forecasts, and regulatory metrics, including tracking and reporting.
Represent regulatory processes during internal and external audits and drive continuous enhancement.
Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
Build and lead a high-performing team by fostering engagement, developing talent, and cultivating a culture of accountability and growth.
What You Need:
Required
Bachelor’s Degree required. Preferably in Science or Engineering.
6+ years of related experience. Preferably within a regulated industry such as medical device, pharmaceutical, biotechnology, or other highly controlled environments.
3+ years of Quality or Regulatory Affairs experience.
Previous experience in a technical function (i.e. Engineering, Quality, Clinical, Pre or Post Market Regulatory, Manufacturing).
Preferred:
Prior supervisory experience is a plus!
Advanced degree/RAC Certification is a plus!
$115,600 - $155,000 - $190,400 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%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.