Biocompatibility specialist

We need a biocompatibility specialist who can review existing biocompatibility reports, extract required data, and populate our Agile PLM system. This work supports a major compliance initiative and covers 40,000 products, so accuracy, consistency, and regulatory expertise are essential.

Key Responsibilities

• Review biocompatibility reports for all product families and SKUs.
• Interpret and extract required data elements such as:
• Biological evaluation summaries
• Cytotoxicity, sensitization, irritation test results
• Material composition and hazardous substances
• Sterilization method impacts
• Chemical characterization data
• Ensure all extracted data aligns with ISO 10993 requirements.
• Populate and update Agile PLM fields with biocompatibility and material compliance data.
• Identify missing, outdated, or inconsistent biocompatibility documentation.
• Work with Regulatory, R&D, and Quality teams to resolve gaps or unclear data.
• Support compliance with:
• ISO 10993 series
• EU MDR material safety requirements
• FDA biocompatibility guidance
• Hazardous substance regulations (RoHS, REACH, Prop 65, etc.)
• Maintain audit‑ready documentation and traceability for all updates.
• Help standardize biocompatibility data structures across 40,000 products.

Required Skills & Qualifications

• Deep knowledge of ISO 10993 (biological evaluation of medical devices).
• Experience reading and interpreting:
• Biocompatibility test reports
• Material declarations
• Chemical characterization reports
• Toxicological risk assessments
• Strong understanding of hazardous substances and global material compliance:
• REACH
• RoHS
• SVHC
• MDR Annex I
• Experience with Agile PLM or similar systems.
• Ability to work through large volumes of documentation with precision.
• Strong analytical skills and attention to detail.
• Experience in medical devices, biotech, or regulated manufacturing.
• Ability to collaborate with Regulatory, Quality, and R&D teams.

ABOUT BRICKRED SYSTEMS

BrickRed Systems is a global leader in next-generation technology consulting and workforce solutions, specializing in delivering high-quality talent across digital, engineering, healthcare, analytics, finance, operations, and business transformation domains. With a strong emphasis on innovation, scalability, and client success, BrickRed Systems helps organizations solve complex business challenges by providing skilled professionals across strategy, technology, creative, and operational functions.

BrickRed Systems fosters a culture of continuous learning, collaboration, and excellence, enabling professionals to contribute to high-impact global initiatives while advancing their careers.