Sr Biocomptibility Specialist

ConvaTec Inc; Manchester; On-site; GBP 60,000 - 90,000; Full time

Job summary

Convatec's Applied Research in Biomedical Sciences seeks a Senior Biocompatibility Specialist to lead biological evaluations for NPD and LCM, applying deep biocompatibility expertise to design studies and generate regulatory-ready documentation.

You will work with NPD, regulatory, project management, and external labs to derisk programs, develop testing strategies, and ensure global regulatory acceptance, with travel up to 20%.

Qualifications

• BS in Biomedical Engineering, Bioengineering, Biology, Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; MS/PhD preferred.
• +5 years biocompatibility evaluations or toxicological risk assessments of medical devices.
• Strong knowledge of ISO 10993 standards and regulatory expectations.
• Ability to develop and drive detailed project plans with dependencies.
• Excellent analytical, writing, and communication skills; cross-functional collaboration.

Responsibilities

• Deliver biological evaluations of new and existing devices in collaboration with project teams.
• Evaluate biocompatibility studies conducted by external laboratories in support of programs.
• Develop or revise biological evaluation protocols, reports, and regulatory summaries.
• Interpret biocompatibility data and report to project teams and regulatory stakeholders.
• Collaborate with regulatory affairs to align requirements for biological evaluations.
• Contribute to updating internal and external guidance documents related to biocompatibility.
• Travel up to 20% domestically and overseas as appropriate.
• Communicate progress via meetings, presentations, and reports.

Skills

Biocompatibility expertise

Education

BS in Biomedical Engineering / Biology / Biochemistry / Materials Science / Toxicology

MS or PhD preferred

Job description

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 as well as in the form of presentations and reports.
• Effectively collaborate with project management, R&D, Regulatory, manufacturing, process engineering Global Laboratory Services etc. teams, ensuring teams are aligned on key goals, deliverables, resource needs, timelines etc.
• Promote teamwork within and across departments, sharing experiences and best practices. Strive for high performing teams behaviours and activities both within the biocompatibility and Applied Research teams and between project, regulatory and other cross functional teams.

Authority (if applicable): Authority over the Biological evaluations. Principal Contacts Internal · New Product Development & Life Cycle Management Teams as teammates on project work. To align on test strategies and biocompatibility strategy, agree timelines and budgets, communicate progress and risks. · Scientific & Technical Labs to execute testing, as required. · Regulatory Affairs to collaborate on requirements for biological evaluations. · Project Management to estimate resource requirements, identify key milestones, manage project governance, and develop timelines. · Applied Research to leverage other scientific and engineering capabilities outside of Adhesives. · Quality to support audits on questions related to biocompatibility and to work in a compliant way within the QMS.
· Medical affairs to understand clinical use cases. External · Laboratory Testing Services to contract necessary testing. · Regulatory agencies to explain and defend biological evaluations or answer questions.

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,

• +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 deliverable
• Ability to demonstrate a high level of creativity and independence in areas of assigned responsibility and has good command of the relevant scientific and technical literature.
• Demonstrates 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.
• undefined

Travel Requirements Up to 20% travel domestically and overseas including overnight travel as appropriate. Languages · Speaking: Yes English · Writing/Reading: Yes English

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 SciTech 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.