Work Flexibility: Remote. Stryker is seeking a Principal Specialist, Regulatory/ Clinical Science (Biocompatibility & Sterility) for our Orthopedic Technologies Division | Mako & Enabling Technologies. This is a remote position based in the Eastern Time Zone. As the Principal Specialist, Regulatory Science, you will provide both strategic direction and hands-on technical leadership in biocompatibility and sterility, ensuring consistent, compliant, and scalable practices across product development and sustaining activities. You will operate as a senior individual contributor driving alignment, standards, and execution across the business. What You Will DoDefine and implement Clinical Sciences strategies for biocompatibility and sterility across new product development and sustaining programs. Lead development of quality system frameworks, standards, and processes to support compliant clinical science practices. Own and deliver clinical sciences work products, including test strategies, risk assessments, and regulatory documentation. Provide technical leadership on biocompatibility evaluations (ISO 10993), sterilization validation (e.g., EO, radiation), and microbiological risk. Integrate clinical science strategies with risk management and design controls to ensure alignment across product lifecycle stages. Identify and implement process improvements, standardization, and tools to enhance efficiency, reduce rework, and improve quality outcomes. Partner with cross-functional teams to influence program decisions, resolve technical challenges, and maintain execution timelines. Mentor team members and contribute to building scalable capabilities through development of best practices and technical frameworks. What You Need. Required. Bachelor’s degree in Biomedical Engineering, Biology, Microbiology, Materials Science, or related field. Minimum 10 years of experience in the medical device industry with focus on biocompatibility and/or sterility. Demonstrated expertise in ISO 10993 biocompatibility standards and sterilization validation methods. Experience applying ISO 14971 risk management principles within product development. Preferred. Advanced degree (Master’s or PhD) in a related scientific discipline. Experience supporting orthopedic, robotic, or implantable medical device products. Experience supporting regulatory submissions, audits, or inspections. Experience developing or scaling technical functions, frameworks, or processes United States of America Pay Ranges:Puerto Rico: $102,600 - $171,000 USD Annual. USN: $110,100 - $183,400 USD Annual. US 5: $115,600 - $192,600 USD Annual. US 10: $121,100 - $201,700 USD Annual. US 15: $126,600 - $210,900 USD Annual. US 20: $132,100 - $220,100 USD Annual. US 30: $143,100 - $238,400 USD Annual. View the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 10%