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Senior Biocompatibility Specialist
2 months ago
Abbott Laboratories is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
We're seeking a highly skilled Senior Biocompatibility Specialist to join our team at Abbott Vascular. As a key member of our cross-functional team, you will be responsible for ensuring the biological safety of our medical devices, collaborating with R&D groups, Preclinical, Regulatory, Analytical Chemistry, and Quality groups to support multiple projects.
Key Responsibilities- Deliver biocompatibility assessments and evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
- Collaborate with a cross-functional team to support multiple projects requiring biocompatibility evaluation, ensuring timely completion of required tasks to meet project schedules.
- Interact directly with functional groups, including R&D groups, Preclinical, Regulatory, Analytical Chemistry, and Quality groups, in the Abbott various business Divisions and CROs.
- Analyze biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem-solving skills and technical knowledge to troubleshoot unexpected results.
- Assist with regulatory submissions to global regulatory agencies to elaborate on the biocompatibility strategy and data in response to additional information requests.
- Participate in design and risk review meetings to address device biological safety concerns and ensure proper records of biological safety assessments and test plans/reports.
- Maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
- Perform and assist gap analysis of external standards, regulatory requirements, and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on Abbott medical devices and business.
- Participate in the development and implementation of overall biocompatibility strategies.
- Bachelor's degree in biology, biochemistry, toxicology, molecular cell biology, immunology.
- Minimum 15 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations with a focus in medical devices.
- Good understanding of and experience applying the principles, theories, and concepts in biocompatibility per ISO 10993.
- Experience with toxicological assessments, chemical characterization, material characterization, processes for medical device manufacturing, and/or biocompatibility assessment.
- Experience in US and global regulations (e.g., EU, China, Korea, and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993.
- Experience working with scientific standard organizations (e.g., ISO/TC 194).
- Strong computer and general software skills.
- Strong oral/written communication skills.
- Master's or PhD degree in biology, biochemistry, toxicology, molecular cell biology, immunology; preferably with a specialism relating to medical devices.
Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical coverage, retirement savings, tuition reimbursement, and education benefits. Join our team and build a fulfilling career with a company that values your growth and well-being.
Learn more about our company culture and benefits at www.abbott.com/careers.
The base pay for this position is $125,300.00 – $250,000.00, depending on location.
