Lead Scientist, Biocompatibility Assessment
2 weeks ago
Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage. Our extensive portfolio encompasses transformative technologies across various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medicines.
With a workforce of 114,000 professionals, we are committed to serving communities in over 160 countries.
Position SummaryAs a Senior-level contributor, you will play a pivotal role as a Subject Matter Expert (SME) in biocompatibility, concentrating on the toxicological and biocompatibility evaluations necessary for the approval and safety of Abbott's medical devices, adhering to global regulatory standards.
Key Responsibilities- Conduct comprehensive biocompatibility assessments and develop evaluation plans and reports in alignment with relevant biological evaluation standards and FDA/ISO guidelines.
- Collaborate with cross-functional teams to support various projects requiring biocompatibility evaluations, ensuring timely task completion to meet project timelines.
- Engage directly with diverse functional groups, including R&D, Preclinical, Regulatory, Analytical Chemistry, and Quality Assurance.
- Analyze biocompatibility test outcomes to evaluate data adequacy for biological effects, employing problem-solving skills to address unexpected results.
- Assist in regulatory submissions to global agencies, elaborating on biocompatibility strategies and responding to additional information requests.
- Participate in design and risk review meetings to address biological safety concerns, ensuring proper documentation of assessments and reports.
- Maintain up-to-date knowledge of applicable external standards and industry requirements for medical device biological safety.
- Conduct gap analyses of external standards and regulatory requirements related to biological safety evaluations, mitigating potential impacts on Abbott's medical devices.
- Contribute to the development and implementation of comprehensive biocompatibility strategies.
Required:
- Bachelor's degree in biology, biochemistry, toxicology, molecular cell biology, or immunology.
- A minimum of 15 years of relevant industrial experience in an FDA/ISO regulated environment focusing on biological safety evaluations for medical devices.
- Proficient understanding and application of biocompatibility principles as per ISO 10993.
- Experience in toxicological assessments, chemical and material characterization, and biocompatibility evaluation.
- Familiarity with US and global regulations concerning biocompatibility and safety testing.
- Strong computer skills and effective oral/written communication abilities.
Preferred:
- Master's or PhD degree in a relevant field, ideally with a specialization in medical devices.
At Abbott, you will have the opportunity to engage in meaningful work, pursue career growth, and maintain a healthy work-life balance. We offer competitive benefits, including:
- Comprehensive medical coverage for employees.
- Robust retirement savings plans with significant employer contributions.
- Tuition reimbursement and educational benefits for career advancement.
Join us at Abbott, where your career aspirations can flourish in a diverse and inclusive environment.
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