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Research and Development Leader

2 months ago


Bath, Bath and North East Somerset, United Kingdom Cure Talent Full time
Job Description

Cure Talent is proud to partner with Phenutest Diagnostics, a pioneering Point of Care Diagnostics MedTech Start-Up, in their search for a visionary Research & Development Director.

Key Responsibilities:

  • Lead the Laboratory team in the development and advancement of Phenutest Diagnostics' unique IVD product, overseeing product testing during its developmental phase.
  • Collaborate closely with the Regulatory Affairs team to support and drive Regulatory Submissions, primarily in the US.
  • Develop and implement Laboratory Processes to support testing according to best practice and regulatory standards.
  • Oversee the preparation of analytical performance data for new product approvals.
  • Manage the laboratory team to deliver tests to schedule, ensuring that all projects are aligned with business objectives and are executed efficiently.
  • Lead the development and integration of new technologies, methodologies, and platforms that enhance the company's IVD capabilities.

Requirements:

  • Degree education in a relevant field, such as Microbiology, Biochemistry, or Biomedical Engineering.
  • Proven track record of testing IVD products from point of concept to commercialization, including the preparation of analytical data for submissions and approvals.
  • In-depth experience and knowledge of IVD technologies, including Molecular Diagnostics, Immunoassays, and Point of Care testing.