Senior Biocompatibility Specialist
7 days ago
Abbott, a leading global healthcare company, is seeking a highly skilled Senior Biocompatibility Specialist to join our team. As a key member of our Research and Discovery team, you will play a critical role in ensuring the safety and efficacy of our medical devices.
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 cross-functional teams 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, Preclinical, Regulatory, Analytical Chemistry, and Quality groups, to ensure seamless communication and collaboration.
- Analyze biocompatibility test results to determine adequacy of data to meet requirements for 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.
- Bachelor's degree in biology, biochemistry, toxicology, molecular cell biology, immunology, or a related field.
- Minimum 15 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations with a focus on 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, or a related field, preferably with a specialization relating to medical devices.
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Senior Biocompatibility Specialist
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Gondrecourt-le-Château, Grand Est, United States Abbott Laboratories company Full timeAbout the RoleWe are seeking a highly skilled Senior Biocompatibility Specialist to join our team at Abbott Laboratories. As a key member of our organization, you will play a critical role in ensuring the safety and efficacy of our medical devices.Key ResponsibilitiesDeliver biocompatibility assessments and evaluation plans and reports complying with...
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Biocompatibility Expert
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Gondrecourt-le-Château, Grand Est, United States Abbott Full timeAbout the RoleWe are seeking a highly skilled Senior Biocompatibility Specialist to join our team at Abbott. As a key member of our Research and Development team, you will be responsible for ensuring the safety and efficacy of our medical devices.Key ResponsibilitiesDeliver biocompatibility assessments and evaluation plans and reports complying with...
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