Hiring: Principal Regulatory Affairs Specialist, (Hybrid) Company: Stryker Location: Portage, MI Job Posted Time: 2026-09-10 11:22:45 Employment Type: Hybrid Target Skills & Keywords : Quality Assurance, Regulatory Compliance About the job Experience: •8 years of relevant Regulatory Affairs/ Quality Assurance experience within an FDA-regulated industry. •Minimum 8 years of relevant Regulatory Affairs/ Quality Assurance experience within an FDA-regulated industry. Required Skills: •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. •Partner cross-functionally 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. Qualifications: •Bachelor's degree required. Degree in Engineering, Biological Sciences or equivalent focus preferred. •Applied knowledge of FDA regulations and regulatory compliance requirements. •Master's degree in Regulatory Affairs or related discipline. •Medical device industry experience is strongly preferred. •Demonstrated ability to assess regulatory and quality risks, navigate ambiguity, and influence stakeholders across complex organizations. •View the U.S. work location and transparency guide to find the pay range for your location. Compensation: •$126,500 - $210,700 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!