Principal Specialist, Regulatory Science
New
United States, Eastern Time ZoneFull-TimePrincipal
Salary102,600 - 238,400 USD per year
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Job Details
- Experience
- Minimum 10 years of experience in the medical device industry
- Required Skills
- Risk Management
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
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
- Identify and implement process improvements and standardization
- Partner with cross-functional teams to influence program decisions
- Mentor team members and build scalable capabilities
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