Sr Biocomptibility Specialist

Convatec is entering an exciting new phase of its R&D journey with plans to establish a new state-of-the art facility in Manchester. Located within the Citylabs Sci Tech campus, the site is intended to become a key hub within our global R&D network, bringing together advanced analytical research, global laboratory testing, quality control, engineering, science, regulatory expertise and health innovation capabilities.

The facility will strengthen collaboration with Manchester's world-class life sciences ecosystem and support our mission of pioneering trusted medical solutions to improve the lives we touch. Over time, activities currently based at our Convatec Technology Centre in Deeside are expected to transition to the new Manchester location, targeted to open in early 2028. This move will create exciting opportunities to help shape the future of healthcare innovation at Convatec.

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 (a) effectively supports and delivers biocompatibility assessments for NPD and LCM. Derisks NPD and research projects at an early stage as well as (b) completion of biological evaluation plans and reports that are accepted by regulatory authorities globally including in US, UK, Europe and Rest of World.

• 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 in order to deliver feedback and data that support device development
• 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.
• Make positive contributions to recommend approaches to, and support updating/ developing procedures for internal and external guidance document as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA).
• Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable, chemical characterization and biological evaluations
• Write, edit, and/or approve technical documentation.
• Communicate effectively to expert and non-expert audiences with regular project updates in meetings…