Senior Biocompatibility Specialist

7 days ago


GondrecourtleChâteau, Grand Est, United States Abbott Full time
About the Role

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.
Requirements
  • 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.
Preferred Qualifications
  • 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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