Biocompatibility Expert @ Tata Elxsi

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Biocompatibility Expert

Tata Elxsi
8 - 15 years
Pune
11 days ago
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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.

Job Classification

Industry: Miscellaneous
Functional Area / Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Pharmaceutical & Biotechnology - Other
Employement Type: Full time

Contact Details:

Company: Tata Elxsi
Location(s): Pune

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Keyskills: Biocompatibility Toxicology MDR BEP 10993 BER

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Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Tata Elxsi

Wipro Ltd (NYSE:WIT) is a global information technology, consulting and outsourcing company with 170,000+ workforce serving clients in 175+ cities across 6 continents. \r\n\r\nWipro helps customers do business better by leveraging our industry-wide experience, deep technology expertise, comprehensiv...

Biocompatibility Expert @ Tata Elxsi

Home > Pharmaceutical & Biotechnology