Biocompatibility Specialist II

2 weeks ago


Glasgow, Glasgow City, United Kingdom ConvaTec Full time
About the Role:

Convatec is a global medical products and technologies company, committed to improving the lives of millions. We're looking for a Biocompatibility Specialist II to join our team and contribute to our mission.

As a Biocompatibility Specialist II, you will work within prescribed ISO 10993 Standards and ensure specific compliance to all national and international regulations relevant to Biocompatibility. You will function as a Subject Matter Expert (SME) in biocompatibility, supporting Global Operations and Supply in evaluating established device, material, and process changes through the change control process either with Safety Assessments or updates to existing biological evaluations of existing products and associated processes.

Key Responsibilities:

  1. Manage and oversee the SME role for Biocompatibility for all change controls within Convatec QMS.
  2. Investigate and evaluate risk to patients with unintended contamination or processes within a Safety Assessment.
  3. Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.
  4. 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.
  5. Evaluate and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.
  6. 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).
  7. Support biological hazards risk analysis activities.
  8. Interface with and indirectly report to corporate biocompatibility team and represent biocompatibility on project/program teams.
  9. Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations.


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