Sr Biocomptibility Specialist

As part of Convatec's Applied Research organization within the Biomedical Sciences team, the Senior Biocompatibility Specialist is responsible for execution of biocompatibility projects requiring deep expertise in biocompatibility for New Product Development (NPD), Life Cycle Management (LCM) and Research projects.

From a technical standpoint, the Senior Biocompatibility Specialist will apply subject matter expertise in biocompatibility to:

• Design and perform the technical approach to biological evaluations for products.
• Analyze data, reflect on results, report out on data to project teams and complete biological evaluation documentation in line with ISO 10993 series of standards and the quality system.

They will work cross-functionally with other groups such as New NPD, regulatory, Applied Research teams, Project Management and Medical/Clinical, to ensure priorities, goals, deliverables, collaborative needs, and timelines are consistently aligned.

Measures of success include:

• Effectively supports and delivers biocompatibility assessments for NPD and LCM.
• Derisks NPD and research projects at an early stage.
• Completion of biological evaluation plans and reports that are accepted by regulatory authorities globally including in US, UK, Europe and Rest of World.

Responsibilities include:

• Deliver biological evaluations of new and existing devices in close and effective collaboration with the relevant project teams.
• Evaluate projects and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.
• Leverage internal capabilities to support biocompatibility projects.
• Derisk new medical devices and research projects early in the development process.
• 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.
• Make positive contributions to recommend approaches to, and support updating/developing procedures for internal and external guidance documents as they relate to biocompatibility.
• Analyze, interpret, and draw conclusions from biocompatibility testing.
• Write, edit, and/or approve technical documentation.
• Communicate effectively to expert and non-expert audiences with regular project updates in meetings as well as in the form of presentations and reports.

Qualifications:

• Advanced degree (MS or PhD) in relevant fields preferred.
• +5 years related to biocompatibility evaluations and/or toxicological risk assessments of medical devices.
• 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 a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
• Ability to demonstrate a high level of creativity and independence in areas of assigned responsibility.
• Excellent analytical and problem-solving skills and ability to interpret data from a variety of sources.
• Excellent verbal/written communication skills and the ability to work well in cross-functional teams.
• Ability to collaborate effectively to troubleshoot issues, identify solutions and optimise strategies for implementation.
• Demonstrate ability to time manage multiple projects effectively and efficiently and adapt to changing priorities as required.
• Very strong communication and project management skills with multiple teams from different disciplines.

Travel Requirements: Up to 20% travel domestically and overseas including overnight travel as appropriate.