Biocompatibility Specialist - Tata Elxsi, Bangalore/Chennai/Hyderabad/

Job description

**Job description:** 1. Thorough understanding of MDR 2. BEP, BER, CMR-ED, Gap Analysis of the existing documents, if any 3. Material Compliance Key Responsibilities - Define and execute biological evaluation strategies per ISO 10993 and EU MDR. - Review material composition, supplier data, and existing biocompatibility evidence. - Prepare or update Biological Evaluation Plans (BEPs) and Biological Evaluation Reports/Biological Risk Assessments (BERs/BRAs). - Assess data gaps and recommend testing, literature review, or justification approaches. - Collaborate with Toxicology and Risk Management teams for integrated assessments. - Support responses to Notified Body queries related to biocompatibility.