Principal Regulatory Affairs Specialist, (Hybrid)

Work Flexibility: Hybrid Join Stryker's Instruments Division as a Principal Regulatory Affairs Specialist, where you will serve as a key regulatory expert supporting strategic business development and regulatory activities across the product lifecycle. In this highly visible role, you will partner closely with Business Development, Quality, Clinical, and Regulatory leaders to evaluate regulatory and quality risks, support due diligence activities related to acquisitions and partnerships, and help drive informed business decisions. This role offers unique exposure to strategic initiatives, executive stakeholders, and cross-functional collaboration while leveraging your deep regulatory expertise. This unique position offers exposure across multiple functions, providing a career development opportunity beyond a traditional Regulatory Affairs role. Work Flexibly: This is a hybrid role requiring a commutable distance to Portage, MI. Partner with Business Development teams to support regulatory and quality due diligence activities for potential acquisitions. Conduct research and analysis of new technologies, business models, product portfolios, and regulatory landscapes to support strategic decision-making. Lead regulatory strategy development and execution for product development, commercialization, and lifecycle management activities. Collaborate with cross-functional partners to support integration planning and ensure key regulatory and quality considerations are appropriately addressed following acquisitions. Serve as a regulatory subject matter expert on significant projects, providing guidance on applicable regulations, standards, and compliance requirements. Monitor global regulatory changes and communicate impacts, risks, and required actions to project teams and stakeholders. Evaluate regulatory risks and develop mitigation strategies to support business and regulatory objectives. Review project progress, assess regulatory deliverables, and recommend procedural improvements to enhance compliance and efficiency. Collaborate with cross-functional teams to translate complex regulatory requirements into actionable project plans and compliance activities. Required Qualifications Bachelor's degree required. Degree in Engineering, Biological Sciences or equivalent focus preferred. Minimum 8 years of relevant Regulatory Affairs/ Quality Assurance experience within an FDA-regulated industry. Applied knowledge of FDA regulations and regulatory compliance requirements. Preferred Qualifications Regulatory Affairs Certification (RAC). Master's degree in Regulatory Affairs or related discipline. Medical device industry experience is strongly preferred. Experience supporting products throughout the full product lifecycle, including product development, commercialization, post-market activities, and lifecycle management. Experience supporting business development, due diligence, mergers and acquisitions (M&A), licensing activities, or other strategic business initiatives preferred. Demonstrated ability to assess regulatory and quality risks, navigate ambiguity, and influence stakeholders across complex organizations. USN: $126,500 - $210,700 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 20% 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. #J-18808-Ljbffr Stryker Corporation