Toxicologist / Principal Scientist Not right for you? We've got others

$130,000 - $145,000
Oakland, CA
March 17th 2020
Minimum Degree:
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Toxicologist / Principal Scientist – Extractables & Leachables – Medical Device

Position Summary:

Seeking Subject Matter Expert (SME) for a Senior Scientific role with biocompatibility and toxicology expertise in Extractables & Leachables for global medical device company. The right person may be able to work remotely, apply if you are interested and qualified.

Position Responsibilities:

• Senior-level individual contributor responsible testing of medical devices, processes and materials

• Develop protocols, reports, and regulatory summaries in collaboration with cross-functional teams, laboratories and suppliers

• Manage external test labs

• Ensure compliance with global regulatory requirements and standards related to biological safety such as ISO 10993

• Responsible for defining testing strategy based for materials, design and process that satisfy cost and technical requirements

• Analyze biocompatibility testing: extractable and leachable, chemical characterization and biological evaluations

• Author SOPs

• Author regulatory submissions and responses to evaluations

Professional Profile: 

• Ph.D in Toxicology, Biochemistry, Biomedical Engineering, Bioengineering, Biology with 5+ years’ experience or MS Degree with 10+ years’ experience in biocompatibility, toxicology, and/or process validation

• Fundamental understanding of ISO 10993 standards

• Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment

• Must have expertise in toxicity due to related impurities generated from E & L studies and how to classify and justify safe use of Class III medical devices

• Strong ability to critically review detailed scientific information and assess areas for improvement

• Ability to work well with diverse cross-functional teams

• Strong leadership and influencing skills in a cross-functional organizational setting

• DABT Certification is HIGHLY preferred 

• Requires some domestic and international travel


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