Regulatory Affairs Specialist

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. Preferred to be in Engineering, Science, or a related field. Minimum 0 years of experience in regulatory affairs. Preferred 2+ years of experience in regulatory affairs. 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. Compensation USN: $72,500 - $120,900 USD Annual. Travel Travel Percentage: 10%. EEO Statement 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. #J-18808-Ljbffr