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.