Senior Biocompatibility Scientist | Medical Devices

ConvaTec Inc

Manchester

On-site

GBP 60,000 - 90,000

Full time

3 days ago
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Job summary

Convatec's Applied Research in Biomedical Sciences seeks a Senior Biocompatibility Specialist to lead biological evaluations for NPD and LCM, applying deep biocompatibility expertise to design studies and generate regulatory-ready documentation.

You will work with NPD, regulatory, project management, and external labs to derisk programs, develop testing strategies, and ensure global regulatory acceptance, with travel up to 20%.

Qualifications

  • BS in Biomedical Engineering, Bioengineering, Biology, Molecular Cell Biology, Biochemistry, Materials Science, or Toxicology; MS/PhD preferred.
  • +5 years biocompatibility evaluations or toxicological risk assessments of medical devices.
  • Strong knowledge of ISO 10993 standards and regulatory expectations.
  • Ability to develop and drive detailed project plans with dependencies.
  • Excellent analytical, writing, and communication skills; cross-functional collaboration.

Responsibilities

  • Deliver biological evaluations of new and existing devices in collaboration with project teams.
  • Evaluate biocompatibility studies conducted by external laboratories in support of programs.
  • Develop or revise biological evaluation protocols, reports, and regulatory summaries.
  • Interpret biocompatibility data and report to project teams and regulatory stakeholders.
  • Collaborate with regulatory affairs to align requirements for biological evaluations.
  • Contribute to updating internal and external guidance documents related to biocompatibility.
  • Travel up to 20% domestically and overseas as appropriate.
  • Communicate progress via meetings, presentations, and reports.

Skills

Biocompatibility expertise

Education

BS in Biomedical Engineering / Biology / Biochemistry / Materials Science / Toxicology
MS or PhD preferred

Job description

Convatec's Applied Research in Biomedical Sciences seeks a Senior Biocompatibility Specialist to lead biological evaluations for NPD and LCM, applying deep biocompatibility expertise to design studies and generate regulatory-ready documentation.

You will work with NPD, regulatory, project management, and external labs to derisk programs, develop testing strategies, and ensure global regulatory acceptance, with travel up to 20%.

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