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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- Manage and Oversee Biocompatibility Programs
Develop and implement biocompatibility strategies to ensure compliance with global regulatory requirements, including FDA, ISO, MHLW, and CFDA.
Investigate and Evaluate RiskAnalyze and evaluate risk to patients associated with unintended contamination or processes within a Safety Assessment.
Develop Biological Evaluation ProtocolsCollaborate with cross-functional program teams, test laboratories, and suppliers to develop or revise biological evaluation protocols, reports, and regulatory summaries.
Understand Biocompatibility StrategiesDevelop a deep understanding of biocompatibility strategies that consider 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 StudiesEvaluate and execute biocompatibility studies conducted by external laboratories in support of programs dealing with our medical devices.
Support Biological Hazards Risk AnalysisSupport biological hazards risk analysis activities to ensure the safety of our medical devices.
Interface with Corporate Biocompatibility TeamInterface with and indirectly report to the corporate biocompatibility team and represent biocompatibility on project/program teams.
Analyze and Interpret Biocompatibility TestingAnalyze, interpret, and draw conclusions from biocompatibility testing, including extractable and leachable chemical characterization and biological evaluations.
About You- 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.
ExperienceFundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
SkillsCapable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
Languages- English
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. This is a role that will challenge you and move you to make a difference in the medical device industry.
