Associate Manager, Regulatory Affairs

Associate Manager, Regulatory Affairs

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!

Salary: $115,600 - $155,000 - $190,400 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.