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- Identify missing, outdated, or inconsistent biocompatibility documentation.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.
- Solid 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

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📌 Biocompatibility specialist (India)
🏢 BrickRed Systems
📍 India