We 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.

• 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 in order 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 the proper records of biological safety assessments and test plans/reports.

• 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 of 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 organization (e.g. ISO/TC 194).

• Master's or PhD degree in biology, biochemistry, toxicology, molecular cell biology, immunology; preferably with a specialism relating to medical devices.