Staff Regulatory Affairs Specialist (Pharmaceutical Products)

Job Title and Overview Work Flexibility: Hybrid Stryker is seeking a Staff Regulatory Affairs Specialist, (Pharmaceutical Products) to join our Medical Division. This is a hybrid role based in Cary, IL. As the Staff Regulatory Affairs Specialist, you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. You will research requirements (local, national, international), applicable guidance and standards and options of regulatory submissions, approval pathways, and compliance activities. Key Responsibilities Prepare and author annual reports and other regulatory submissions required for approved pharmaceutical products. Assess product, process, and manufacturing changes to determine appropriate regulatory reporting requirements and submission pathways. Develop and submit amendments, supplements, and other regulatory filings in accordance with applicable regulations and guidance. Review technical documentation and regulatory content to ensure accuracy, completeness, and submission readiness. Research regulatory requirements, standards, guidance documents, and approval pathways to support product development and lifecycle management. Communicate with regulatory agencies regarding submission strategies, regulatory pathways, submission status, and responses to agency inquiries. Partner with engineering, quality, clinical, manufacturing, and marketing teams to support regulatory objectives during product development and sustaining activities. Develop and communicate regulatory guidance, requirements, and compliance considerations to support business and project goals. Requirements Required: Bachelor’s degree in Science, Engineering, Regulatory Affairs, or a related discipline. Minimum 4 years of experience in an FDA-regulated or other highly regulated industry. Minimum 2 years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry. Experience reviewing regulatory requirements and assessing regulatory impact of product, process, or manufacturing changes. Experience preparing, authoring, or supporting drug regulatory submissions, including submissions for product approvals, post-approval changes, or lifecycle management activities. Preferred: Regulatory Affairs Certification (RAC) or Master’s degree in Regulatory Affairs or a related field. Experience preparing or supporting international regulatory submissions and registrations. Experience interacting directly with regulatory agencies. Regulatory Affairs Certification (RAC) or Master’s degree in Regulatory Affairs or a related field. Compensation & Work Flexibility US10: $105,300 - $175,500 USD Annual Travel Percentage: 0% 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. About Stryker 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 Definition 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. #J-18808-Ljbffr Stryker Corporation