Biocompatibility Specialist - Deeside, United Kingdom - ConvaTec

ConvaTec
ConvaTec
Verified Company
Deeside, United Kingdom

4 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a FTSE 100 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 and critical care, and infusion care.

Group revenues in 2021 were over $2 billion.

With around 10,000 colleagues, we provide our products and services in over 100 countries, united by a promise to be forever caring.

Our products provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.


Job Summary:

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 the R&D and Sustaining Engineering Group (SEG) in biological evaluations of New Product Development and existing products and associated process and material changes.

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.


Duties and Responsibilities

  • Develop or revise biological evaluation protocols, reports, and regulatory summaries in collaboration with crossfunctional 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

Principal Contacts

  • Internal
  • Manufacturing, Supply Chain, Research and Development, Quality Assurance and Regulatory Affairs personnel


  • External

  • Suppliers

Travel Requirements
Some travel will be required: 5-15% of the year.


Education/Experience/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
  • Strong industrial experience in the field of Medical Device, Pharmaceutical, or Biotechnology with expertise in biocompatibility, toxicology, and/or special process validation
Experience

  • 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

Competencies

  • Decide: Drives strategic alignment with focus on core objectives; ensures decisionmaking considers the impact on other team's functions and is timely, efficient and wellinformed; seeks to understand and support decisions made or disagrees constructively with them; appropriately delegates decision making; uses initiative and takes calculated business risks; is compliant with all laws and regulations.
  • Innovate: Challenges the status quo and delivers competitive solutions; actively encourages change and continuous improvement; seeks differing viewpoints; critically evaluates risk and benefit tradeoffs for own team and the company as a whole; is consistently curious and demonstrates support for new ideas and changes raised by others.
  • Engage: Collaborates with internal and external colleagues and stakeholders to achieve long and shortterm results; positively influences others to facilitate effective decision making; shares insights to impact thinking; demonstrates commitment to "One Team"; demonstrates the "Be Here Now" state of mind; listens to understand; questions to seek others' perspective; communicates information and decisions openly and honestly; inspires others by demonstrating resilience, integrity and passion.
  • Execute: Drives focused execu
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