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Identify missing, outdated, or inconsistent biocompatibility documentation.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
Robust 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 consu

📌 Biocompatibility specialist (Hyderabad)
🏢 BrickRed Systems
📍 Hyderabad