R&D Director

Cure Talent are delighted to be partnered with Phenutest Diagnostics, a groundbreaking Point of Care Diagnostics MedTech Start-Up, in their search for an innovative Research & Development Director.

In this newly created position, you will be responsible for the leadership of their Laboratory team, assisting them in the development and advancement of their unique IVD product. You will oversee product testing during its developmental phase and working closely with the RA time to support and drive Regulatory Submissions, primarily in the US.

To be successful as their new Research & Development Director we are looking for a proven leader with an in depth understanding and experience of IVD technologies. You will possess a demonstrable track record of testing Diagnostic products from point of concept through to commercialization.

Responsibilities

• Responsible for integration of benchtop assays onto custom disposable devices for use with their point of care IVD system.
• Lead non-clinical performance testing of our diagnostics system, from concept through to commercialization, ensuring timelines, budgets, and quality/regulatory standards are met.
• Set up Laboratory Processes to support testing according to best practice / regulatory standards.
• Oversee the preparation of analytical performance data for new product approvals.
• Manage 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.

Experience, Skills and Knowledge

• Degree education in a relevant field i.e. Microbiology, Biochemistry, Biomedical Engineering etc.
• Sustained experience within R&D within the In Vitro Diagnostics or Point of Care Diagnostics industries
• Demonstrable experience in leadership roles in R&D
• Proven track record of testing IVD products from point of concept to commercialisation, including the preparation of analytical data for submissions & approvals
• In-depth experience and knowledge of IVD technologies, including Molecular Diagnostics, Immunoassays and Point of Care testing

If you have the required skills and experience and want to join an innovative, growing company, please get in touch with Kris Holmes or apply today!