Regulatory Affairs Specialist

Work Flexibility: Hybrid Join Stryker as a Regulatory Affairs Specialist in Portage, MI supporting Instruments – Surgical Technologies. This role will support regulatory activities for the Neptune Waste Management System, ensuring continued market access, compliance, and lifecycle management across global markets. You will partner with cross-functional teams to evaluate product changes, maintain regulatory approvals, and support strategic initiatives that enable ongoing commercialization, refurbishment, and expansion efforts. What you will do Assess regulatory intelligence and summarize implications for local, regional, and global regulatory strategies. Evaluate product and process changes for regulatory impact across the device lifecycle, including updates, enhancements, and maintenance activities. Identify regulatory risks and propose mitigation plans throughout the product lifecycle. Partner with cross-functional teams (R&D, Quality, Marketing) to ensure alignment of regulatory requirements and claims strategy. Prepare, review, and support submission of regulatory filings for product changes, global registrations, and lifecycle management activities. Monitor regulatory submissions and communicate status updates to internal stakeholders and regulatory authorities. Review marketing and promotional materials to ensure compliance and alignment with approved regulatory claims. Support development and maintenance of a centralized claims library to enable compliant and efficient marketing updates. Support state licensing and other regulatory compliance activities as needed. What you will need Required Bachelor’s degree required. Preferred to be in Engineering, Science, or related field. Minimum 0 years of experience in regulatory affairs. Preferred 2+ years of experience in regulatory affairs preferred. Master’s degree in Regulatory Science. Regulatory Affairs Certification (RAC). Demonstrated experience (academic, internship, or co-op) supporting regulatory documentation, submissions, or compliance activities in a regulated environment. Experience interacting with regulatory authorities (e.g., FDA, EU Competent Authorities). Experience interpreting and applying regulatory requirements across product lifecycle stages. USN: $72,500 - $120,900 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. 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. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.