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Biocompatibility Specialist II
2 months ago
We are seeking a highly skilled Biocompatibility Specialist II to join our team at ConvaTec, a global leader in medical products and technologies. As a Biocompatibility Specialist II, you will play a critical role in ensuring the safety and efficacy of our medical devices.
Key Responsibilities- Biocompatibility Risk Management: Manage and oversee the SME role for Biocompatibility for all change controls within our Quality Management System (QMS).
- Investigation and Evaluation: Investigate and evaluate risk to patients with unintended contamination or processes within a Safety Assessment.
- Biological Evaluation Protocols: Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.
- Biocompatibility Strategies: Understand biocompatibility strategies that are formed in consideration of product and process changes, gaps in materials, design and process to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.
- Biocompatibility Studies: Evaluate and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.
- Procedure Development: Make positive contributions to, recommend approaches to, and support updating/developing procedures for internal and external guidance documents as they relate to biocompatibility, in compliance with applicable global regulatory requirements (FDA, ISO, MHLW, and CFDA).
- Biological Hazards Risk Analysis: Support biological hazards risk analysis activities.
- Interface and Representation: Interface with and indirectly report to corporate biocompatibility team and represent biocompatibility on project/program teams.
- Biocompatibility Testing: Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations.
- Education: BS in one or more of the following disciplines: Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; advanced degree (MS or PhD) in these fields preferred.
- Experience and Skills: Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
- Project Management: Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
- English
We offer a dynamic and challenging work environment that will bring the best out in you. You'll be encouraged and supported to make things happen, and your progress will help improve the lives of millions. This is a role that will challenge you and help you grow professionally and personally.
