Biocompatibility Specialist II

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.

At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Biocompatibility Specialist II, and you’ll do the same.

About the role: Works within prescribed ISO 10993 Standards and ensures specific compliance to all national and international regulations relevant to Biocompatibility. Function as a Subject Matter Expert (SME) in biocompatibility at Convatec 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. Support projects/programs in terms of biocompatibility of medical devices, materials, and processes. This role will work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory and internal requirements.

Your key duties and responsibilities:

• Manage and oversee the SME role for Biocompatibility for impacts to devices relating to changes managed through Change Control (CCRs) and new product development projects within Convatec.
• Mentor the biocompatibility team of SMEs through project assignment and technical reviewing.
• Investigate and evaluate risk to patients with unintended contamination or processes within a Safety Assessment.
• 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.
• Evaluate and execute biocompatibility studies, conducted by external laboratories, in support of programs dealing with our medical devices.
• 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).
• Support biological hazards risk analysis activities.
• Interface with and indirectly report to corporate biocompatibility team and represent biocompatibility on project/program teams.
• Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable, chemical characterization and biological evaluations.
• Participate in industry related standard committees, conferences, and scientific communities as appropriate and able to.

Skills & Experience:

• Fundamental understanding or direct experience of the ISO 10993 standards, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
• Basic knowledge of FDA and international medical device regulations/directives and working knowledge of GMP/ISO/GLP guidelines as applied to medical device testing and documentation.
• Have the ability to work with people and teams in a complex, changing environment and be able to deliver value added results to the business on time.
• Be fully competent in oral and written communications including strong documentation skills.
• Ability to collaborate across multiple internal disciplines and global cultures.
• Solid technical writing that is business friendly to support robust conclusions and submissions to authorities.
• Ability to define, document, and communicate standard operating procedures designed for compliance, accuracy, efficiency, and simplicity.

Qualifications/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.
• +3 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 to a detailed project plan with scheduled and defined dependencies between tasks and deliverable.

Travel Requirements: The position may involve occasional travel up to 5-15%, both domestically and overseas. Most trips will include overnight travel.

Working Conditions: This role may be based in the UK with a remote working structure. May need to support global discussions in different time zones.

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it. This is stepping up to a challenge. This is work that’ll move you.