Overview

The Biocompatibility Specialist role is a full-time, contracted, position serving as Groenakker's technical authority for the biological evaluation of medical devices. As part of Groenakker's global Operations team, this role owns biological evaluation planning and reporting, defines and defends test strategy across the ISO 10993 series, and provides direct technical support to medical device manufacturers through regulatory review. The scope of this role is medical device biological safety specifically, not general chemical, industrial, or consumer product safety assessment.

Engagement Model

• The role is fully remote and open to candidates located anywhere in India and will report to Groenakkers Chennai-based management team.
• Sufficient overlap with United States Eastern Time is required to support client calls and internal review; a minimum of three overlapping working hours per business day is expected.
• Skilled written and spoken English fluency is required, as all deliverables and client communications are produced in English.





Essential Duties And Responsibilities

• Author, review, and defend Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) for medical devices in accordance with ISO 10993-1 and the FDA guidance “Use of International Standard ISO 10993-1” (2023).
• Establish device categorization by nature and duration of body contact, determine the biological endpoints requiring evaluation, and justify how each endpoint is addressed through existing data, chemical characterization, or testing.
• Design biological test programs and specify extraction conditions, extraction ratios, vehicles, and required sample quantities in accordance with ISO 10993-12, using surface- area-based sample sizing for solid devices.
• Select, qualify, and technically oversee contract laboratories, including protocol review, study monitoring, and audit of final reports for scientific and regulatory adequacy.
• Apply the relevant parts of

📌 Biocompatibility Specialist (Chennai)
🏢 Groenakker
📍 Chennai