Job Description & Details
This role puts you at the intersection of biological safety, regulatory remediation, and orthopedic product lifecycle management. You will be driving critical biocompatibility assessments and risk evaluations to keep legacy and sustaining products compliant and on the market. If you enjoy digging deep into ISO 10993 and collaborating across engineering and regulatory teams, this is a high-impact position.
What You'll Actually Be Doing
Expect to spend a good chunk of your time reviewing technical documentation, authoring biological safety risk assessments, and coordinating laboratory studies for orthopedic devices. You will act as the resident subject matter expert, guiding cross-functional partners through tricky regulatory hurdles and translating complex scientific data into clear strategies. Much of the job involves untangling legacy documentation and aligning testing strategies with current regulatory expectations.
The Core Tech Stack
Your bread and butter here will be deep expertise in ISO 10993 biological evaluation standards and medical device risk management. A solid grasp of preclinical in vivo research, large animal model testing, and biocompatibility assessment methodologies is non-negotiable. You also need fluency in regulatory submission processes and technical writing for medical devices.
Interview Expectations
Be ready to walk through a real-world scenario where a biological safety evaluation yielded ambiguous or problematic results, and explain how you navigated the risk assessment to keep the project moving. The hiring manager is testing your pragmatic problem-solving skills and your ability to defend scientific rationale under regulatory scrutiny. Expect another question probing your experience with ISO 10993-1 frameworks, specifically how you justify skipping or adding specific biocompatibility endpoints for a modified orthopedic implant.
Application Advice
Make sure your resume explicitly highlights your hands-on experience with ISO 10993 and biological safety risk assessments rather than just general R&D. Use keywords like biocompatibility, preclinical research, and regulatory remediation verbatim to make it past the initial ATS screening, and frame your past achievements around successful cross-functional product remediation efforts.