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

Salary:
$130,000 - $145,000
Location:
Oakland, CA
Posted:
November 26th 2019
Relocation Assistance:
Available
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Toxicologist / Principal Scientist Extractables & Leachables Medical Device

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 my be able to work remotely, apply if you are interested and qualified.

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

Qualifications

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

Excellent in getting results without direct authority

Requires some domestic and international travel


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