Principal Specialist, Regulatory Science

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 Do

• 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

What You Need

Required

• Bachelors 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 (Masters 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