Website:
syrmajoharimedtech.com
Job details:
Title - Toxicologist Specilaist
Experience - 7 to 8yrs
Location - Pune (WFO)
Job Description
The position is a Senior Toxicologist & Biocompatibility Specialist who acts as the technical owner for biological safety and
toxicological risk across the MedTech lifecycle, with heavy emphasis on ISO 10993, E&L (extractables & leachables), and
Materials of Concern (MoC) programs, especially PFAS. The role is deeply regulatory-facing (EU MDR/IVDR, FDA, Health
Canada, CDSCO), cross-functional, and client-facing, requiring leadership over testing strategy, submissions, audits, supplier
controls, and phase-out planning for restricted substances.
Roles & Responsibility
• Lead biocompatibility evaluations per ISO 10993 and author BERs/TRAs with scientific justifications.
• Design and interpret chemical characterization/E&L studies using advanced analytical techniques.
• Ensure regulatory compliance with EU MDR/IVDR, FDA, ISO 13485/14971, and manage submission packages.
• Drive PFAS/MoC assessments, supplier documentation, and substitution strategies.
• Support design, materials, sterilization, risk management, and PMS activities.
• Lead teams, mentor staff, manage CROs, and support audits and client interactions.
Specific Skill
• Deep expertise in ISO 10993, biological evaluation, and toxicological risk assessment.
• Strong command of E&L analytics and methods such as GC-MS, LC-MS, ICP-MS, FTIR, and DSC.
• Advanced knowledge of PFAS/MoC regulations, material assessment, and substitution strategies.
• Proficiency with FDA, EU MDR/IVDR, ISO 13485/14971 regulatory frameworks.
• Excellent scientific writing, data interpretation, and cross-functional communication skills.
• Strong leadership, project management, and client-facing capabilities.
General Skill
• Strong analytical thinking, problem‑solving, and data‑driven decision‑making abilities.
• Excellent communication skills for translating complex scientific concepts to diverse stakeholders.
• Ability to manage multiple projects, priorities, and timelines efficiently.
• Effective leadership, mentoring, and cross‑functional collaboration capabilities.
• High attention to detail, scientific rigor, and quality‑focused mindset.
• Strong documentation, organization, and audit‑readiness orientation.
Click on Apply to know more.