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

• 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

Posted Date: 06/03/2026
This role will be posted for a minimum of 3 days.

United States of America Pay Ranges:

• Puerto Rico : $102,600 - $171,000 USD Annual
• USN : $110,100 - $183,400 USD Annual
• US5 : $115,600 - $192,600 USD Annual
• US10 : $121,100 - $201,700 USD Annual
• US15 : $126,600 - $210,900 USD Annual
• US20 : $132,100 - $220,100 USD Annual
• US30 : $143,100 - $238,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.