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Biocompatibility Specialist II

2 months ago

Scotland, United Kingdom ConvaTec Full time
About the Role

We are seeking a highly skilled Biocompatibility Specialist II to join our team at ConvaTec. As a key member of our organization, you will play a critical role in ensuring the safety and efficacy of our medical devices.

Key Responsibilities:

  • Manage and oversee the biocompatibility process for all medical devices within our Quality Management System (QMS).

  • Investigate and evaluate risks to patients associated with unintended contamination or processes within a Safety Assessment.

  • Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.

  • 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.

  • Evaluate and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.

  • 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).

  • Support biological hazards risk analysis activities.

  • Interface with and indirectly report to the corporate biocompatibility team and represent biocompatibility on project/program teams.

  • Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations.

Requirements:

  • 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.

  • 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.

  • Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables.

What We Offer:

We offer a dynamic and challenging work environment that will bring the best out in you. You will be encouraged and supported to make things happen, and your progress will help improve the lives of millions. We are an equal opportunities employer and welcome applications from diverse candidates.