Biocompatibility Expert II

3 weeks ago

Scotland, United Kingdom ConvaTec Full time

About Convatec:

Convatec is a global leader in medical products and technologies, dedicated to enhancing the quality of life for individuals with chronic conditions. Our commitment to innovation and excellence is reflected in our diverse range of solutions across advanced wound care, ostomy care, continence care, and infusion care. With a workforce of approximately 10,000 professionals, we operate in nearly 100 countries, united by our mission to provide compassionate care.

Your Role:

As a Biocompatibility Expert II, you will play a crucial role in ensuring the safety and efficacy of our medical devices. Your expertise will guide our biocompatibility assessments and contribute to our continuous improvement efforts.

Key Responsibilities:

  • Lead the subject matter expert (SME) role for biocompatibility within the Convatec Quality Management System (QMS).
  • Conduct thorough investigations and risk evaluations related to patient safety and contamination during safety assessments.
  • Collaborate with cross-functional teams to develop and refine biological evaluation protocols, reports, and regulatory documentation.
  • Formulate biocompatibility strategies considering product and process modifications, ensuring compliance with cost and technical requirements.
  • Oversee and analyze biocompatibility studies conducted by external laboratories for our medical device programs.
  • Contribute to the development and enhancement of internal and external guidance documents regarding biocompatibility, ensuring adherence to global regulatory standards.
  • Assist in biological hazards risk analysis initiatives.
  • Interface with the corporate biocompatibility team and represent biocompatibility interests on project teams.
  • Interpret and analyze data from biocompatibility testing, including extractable and leachable assessments.

Qualifications:

  • A Bachelor's degree in Biomedical Engineering, Bioengineering, Biology, Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; a Master's or PhD is preferred.
  • Strong understanding or direct experience with ISO 10993 standards, biomaterials, toxicological assessments, and medical device manufacturing processes.
  • Proven ability to develop and manage detailed project plans with clear task dependencies and deliverables.

Language Requirements:

  • Fluency in English is required.

At Convatec, we believe in fostering a culture of growth and innovation. You will be encouraged to take ownership of your work and strive for excellence, contributing to meaningful advancements in healthcare.

This is an opportunity to make a significant impact in the medical field.

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