Principal Specialist, Regulatory Science

Stryker is seeking a Principal Specialist in Regulatory/Clinical Science (Biocompatibility & Sterility) for their Orthopedic Technologies Division, focusing on providing strategic and technical leadership in biocompatibility and sterility.

Location: Remote (Eastern Time Zone)

Salary: $102,600 - $238,400 USD Annual (varies by location)

Responsibilities

• Define 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

Requirements

• 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