Manoj Sonavane
Toxicologist at Eurofins - Medical Device Testing
- Role
- Toxicologist at Eurofins
- Location
- Birmingham, AL, US
- LinkedIn followers
- 500 followers
About Manoj Sonavane
Ph.D. in Toxicology with 7+ years of experience in designing, monitoring, analyzing, and…
Experience
Toxicologist
Feb 2023 — Present · Lancaster, PA, US
Conduct toxicological and biocompatibility assessment of client products with regard to product design, design changes, manufacturing process and post-production life-cycle activities, etc- Act as the subject matter expert (SME) for the design and execution of toxicological and biocompatibility testing. Advise on data requirements and biocompatibility and toxicological risk control strategies- Author Toxicological and Biological risk assessments for regulatory compliance- Provide advice on testing strategy and test design- Work with Client/Regulatory Affairs to answer feedback from regulatory agencies on issue relating to biological safety- Prepare and present technical presentations to key stake holders- Maintain and evolve quality system documentation and procedures relevant to toxicological and biological risk assessment- Train staff on new procedures/documents- Maintain strong relationship with internal and external test labs- Remain current and apply the understanding of ISO 10993, ISO 14971, ISO 18562 and regulatory agency guidance documents (e.g. FDA, PMDA etc.) and pertinent quality system requirements.
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