Biocompatibility Specialist II

at  ConvaTec

Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec which 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. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
Our search for better is changing the lives of our customers. It’s changing the careers of our people too –creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as Biocompatibility Specialist, and you won’t either.
As a Biocompatibility Specialist you will work 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 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. You will also support projects/programs in terms of biocompatibility of medical devices, materials, and processes.

• Manage and oversee the SME role for Biocompatibility for all change controls withing Convatec QMS.
• 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.