Biocompatibility Expert II

Transforming healthcare solutions to enhance the lives we impact: Unomedical, part of Convatec, is a worldwide leader in medical products and technologies, dedicated to addressing chronic condition management with top-tier offerings in advanced wound care, ostomy care, continence care, and infusion care. With a workforce of approximately 10,000, we deliver our services and products across nearly 100 nations, united by our commitment to compassionate care. Our innovations yield numerous advantages, from preventing infections and safeguarding vulnerable skin to improving patient outcomes and lowering care expenses. Convatec achieved revenues exceeding $2 billion in 2023 and is a proud member of the FTSE 100 Index (LSE:CTEC). For further insights into Convatec, please visit our website.

Our relentless pursuit of improvement is transforming the experiences of our clients and the careers of our team members, presenting new challenges and opportunities consistently. We are a dynamic organization that continually evolves. Join us on our mission to #ForeverCaring as a Biocompatibility Expert, and you will find your own path of growth.

Key Responsibilities:

• Oversee and manage the Subject Matter Expert (SME) role for Biocompatibility across all change controls within the Convatec Quality Management System (QMS).
• Assess and analyze risks to patients related to unintended contamination or processes during Safety Assessments.
• Collaborate with cross-functional program teams, testing laboratories, and suppliers to develop or update biological evaluation protocols, reports, and regulatory summaries.
• Comprehend biocompatibility strategies that consider product and process modifications, material gaps, and design adjustments to achieve optimal solutions that meet both cost and technical requirements concerning biological safety.
• Evaluate and implement biocompatibility studies conducted by external laboratories to support programs related to our medical devices.
• Contribute positively to, propose methods for, and assist in updating/developing procedures for internal and external guidance documents related to biocompatibility, ensuring compliance with relevant global regulatory standards (FDA, ISO, MHLW, and CFDA).
• Assist in biological hazards risk analysis initiatives.
• Engage with and report indirectly to the corporate biocompatibility team, representing biocompatibility on project and program teams.
• Analyze, interpret, and derive conclusions from biocompatibility testing, including but not limited to extractable and leachable chemical characterization and biological evaluations.

About You:

• Bachelor's degree in disciplines such as Biomedical Engineering, Bioengineering, Biology (Biological Sciences), Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; a master's or doctoral degree in these fields is preferred.
• Solid understanding or direct experience with ISO 10993 standards, biomaterials, toxicological assessments, extractable and leachable analyses, medical device manufacturing processes, and biocompatibility assessment methodologies.
• Able to create and execute a detailed project plan with defined tasks and dependencies.

Languages:

• English

Our aspirations will bring out the best in you. You will be encouraged to aim higher and take ownership of your work. We support and empower you to drive initiatives forward. While the journey may be challenging, the impact of your contributions will enhance the lives of countless individuals, making it a rewarding endeavor.

This is your opportunity to rise to a challenge.

This is work that will inspire you.