Principal Specialist, Regulatory Science
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AI Summary
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
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.
Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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