Lead Toxicologist

Job title : Lead Toxicologist
Location: Bangalore

Role Summary:
We are seeking a Lead Toxicologist (Individual Contributor) to provide end-to-end toxicology and biocompatibility expertise for non-invasive ventilation (NIV) systems, including masks, breathing circuits, tubing, humidification components, and accessories. This is a senior technical individual contributor role responsible for defining toxicology strategy, executing risk assessments, and serving as the primary toxicology subject-matter expert supporting R&D, Regulatory, and Quality teams throughout the product lifecycle.
Key Responsibilities - Toxicology & Biocompatibility Ownership:
- Serve as the toxicology lead for assigned NIV products and platforms.
- Independently develop and execute Biological Evaluation Plans (BEPs) and Biological Evaluation Reports per ISO 10993-1.
- Author, review, and approve Toxicological Risk Assessments (TRAs) per ISO 10993-17.
- Evaluate chemical safety risks from device materials, manufacturing processes, and use conditions.
- Collaborate on material characterization test programs per ISO 10993-18.
Respiratory Device-Specific Responsibilities:
- Assess risks associated with mask interfaces, breathing circuits, tubing, connectors, and humidification systems per ISO 18562.
- Evaluate heat, moisture, airflow, and long-term off-gassing effects.
- Assess cleaning, disinfection, and reprocessing chemical residues.
- Support material selection and supplier qualification.
Regulatory & Standards Support:
- Support FDA submissions, EU MDR Technical Documentation, and global dossiers.
- Act as the primary toxicology contact during regulatory interactions.
- Ensure compliance with ISO 10993 and ISO 14971.
Cross-Functional Technical Leadership:
- Collaborate with R&D, Materials, RA/QA, and Manufacturing.
- Influence design decisions using risk-based toxicological rationale.
- Evaluate toxicology impact of design and supplier changes.
Required Qualifications - Education:
Bachelor's or Master's degree in Toxicology, Chemistry, Biology, Biomedical Engineering, or related discipline. Advanced degree preferred but not required.
Required Qualifications - Experience:
- 8 + years of applied toxicology or biocompatibility experience in medical devices.
- Direct experience with ISO 10993 evaluations.
- Direct experience with ISO 18562 requirements.
- Experience assessing respiratory or inhalation exposure risks.
- Experience supporting FDA and/or EU MDR submissions.
- Experience with reusable devices and reprocessing validation.
- Direct FDA or Notified Body interaction.
Role Characteristics:
- Individual contributor role with no direct reports.
- Hands-on execution and independent judgment.
- Recognized internal expert for complex toxicology decisions.
What Success Looks Like:
- Early identification and mitigation of toxicology risks.
- Efficient, defensible testing strategies.
- Smooth regulatory submissions without biocompatibility delays.