Biocompatibility Specialist II

TN United Kingdom; United Kingdom; Remote; GBP 40,000 - 80,000; Full time

Job summary

Join a pioneering medical solutions company as a Biocompatibility Specialist. You will oversee biocompatibility within the quality management system, assess contamination risks, and develop evaluation protocols. This role offers an exciting opportunity to contribute to innovative solutions that improve patient lives. Collaborate with cross-functional teams and ensure compliance with global regulations while working in a supportive environment that fosters growth and innovation. If you are passionate about making a difference in healthcare, this position is perfect for you.

Qualifications

• BSc in Biomedical Engineering or related field; MSc or PhD preferred.
• Knowledge of ISO 10993 standards and biocompatibility methodologies.

Responsibilities

• Manage biocompatibility within ConvaTec's QMS and assess contamination risks.
• Develop biological evaluation protocols and collaborate with teams.

Skills

Biocompatibility Assessment

Toxicology

Project Management

ISO 10993 Standards

Education

BSc in Biomedical Engineering

MSc or PhD in related fields

Job description

Biocompatibility Specialist II, gdcns, dee

Client: ConvaTec

Location:

Job Category: Other

EU work permit required: Yes

Job Reference: e696a7525fff

Job Views: 3

Posted: 08.05.2025

Expiry Date: 22.06.2025

Job Description:

Pioneering trusted medical solutions to improve the lives we touch: Unomedical, a member of ConvaTec, is a global medical products and technologies company focused on solutions for managing chronic conditions. We hold leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we serve nearly 100 countries, united by a promise to be forever caring. Our solutions benefit patients by preventing infections, protecting at-risk skin, improving outcomes, and reducing costs. ConvaTec’s 2023 revenues exceeded $2 billion and it is part of the FTSE 100 Index (LSE: CTEC). To learn more, visit our website.

Our pursuit of better solutions is transforming lives and careers—creating challenges and opportunities. Join us as a Biocompatibility Specialist and be part of our journey to #ForeverCaring.

Responsibilities:

• Manage and oversee the SME role for Biocompatibility within ConvaTec's QMS.
• Assess risks related to contamination or processes through Safety Assessments.
• Develop or update biological evaluation protocols, reports, and summaries in collaboration with cross-functional teams, labs, and suppliers.
• Formulate biocompatibility strategies considering product and process changes, material gaps, and design to meet safety, cost, and technical requirements.
• Evaluate and execute biocompatibility studies conducted by external labs.
• Support updates and development of procedures and guidance documents related to biocompatibility, ensuring compliance with global regulations (FDA, ISO, MHLW, CFDA).
• Assist in biological hazards risk analysis activities.
• Collaborate with and report to the corporate biocompatibility team; represent biocompatibility on project teams.
• Interpret and analyze biocompatibility testing results, including chemical characterization and biological evaluations.

Qualifications:

• BSc in Biomedical Engineering, Bioengineering, Biology, Molecular Cell Biology, Biochemistry, Materials Science, Toxicology; MSc or PhD preferred.
• Knowledge or experience with ISO 10993 standards, biomaterials, toxicology, extractable/leachable analysis, and biocompatibility assessment methodologies.
• Ability to develop and manage detailed project plans with dependencies.

Languages:

• English

We offer an environment that encourages growth, innovation, and making a difference. Join us to challenge yourself and help improve patient lives.

#LI-CH2

#LI-Remote

Important Notices:

Beware of scams online or from individuals claiming to represent ConvaTec. All formal recruitment processes will be conducted through official channels, including interviews via official ConvaTec email addresses. Do not disclose personal information or pay fees to unknown contacts. For concerns, contact us directly.

Equal Opportunities:

ConvaTec is committed to equal employment opportunities, ensuring no discrimination based on race, religion, gender, age, disability, sexual orientation, gender identity, veteran status, or other protected characteristics.