We are seeking a **Staff Regulatory Affairs Specialist** to join our Medical Division - Acute Care (https://www.stryker.com/us/en/acute-care.html) in **Portage, MI (Hybrid).** As a Staff Regulatory Affairs Specialist, you will support Stryker’s global Acute Care portfolio by maintaining market access and ensuring compliance with evolving regulatory requirements. You will assess device changes, monitor emerging regulatory intelligence, and lead regulatory activities related to wireless technologies. Your work will guide the development, approval, and compliance of innovative medical devices that incorporate wireless communication. **What You Will Do:** + Evaluate device modifications and implement actions to maintain global product compliance. + Analyze emerging regulatory intelligence and advise on potential impact to market access. + Provide regulatory input and technical guidance to product development teams for global requirements. + Determine requirements and options for regulatory submissions, approval pathways, and compliance activities. + Prepare and submit regulatory submissions in alignment with global regulations and guidelines. + Participate in audits to enable or maintain market access across international markets. + Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs. + Support wireless technology compliance within medical devices to meet global regulatory standards. **What You Need:** Required: + Bachelor’s degree (B.S. or B.A.) required, preferably in Engineering, Science, or related field. + 4+ years of experience in a regulated industry required, preferably with medical devices. + Previous experience in Pre- or Post-Market Regulatory, Clinical, Quality, or Engineering. Preferred: + RAC certification or advanced degree (e.g., Master’s in Regulatory Affairs). + General understanding of FDA, EU, and international medical device regulations. 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.