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Posted on July 28, 2021 in UK Jobs

Technical Support Specialist

Who we are

binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing. We also have the broadest suite of offerings in at-home testing for large corporate partners to broaden access to STI and COVID-19 care. Our molecular point of care platform brings rapid, accurate, and convenient infectious disease testing to people where they live, work, and shop. Our at-home solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven, at-home testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.

The Position

We are looking for a Technical Support Scientist to assist with all aspects of technical document authoring and review covering the full breadth of products binx offers (point of care, consumer digital, and instrumentation). Responsibilities will include assay instructions for use, operator manuals, patient specimen collection instructions, marketing documents, presentations, and internal summary documentation. These documents will need to be delivered to the highest standard possible and compliant with the binx health’s quality system. Additionally, the Technical Support Scientist will be responsible for the effective administration of project-specific documentation, ensuring that product requirements are met, documented and tracked. The ideal candidate for this role will have a keen eye for detail and meticulous organizational skills. This role will work across multiple functions at binx (R&D, Operations, Commercial, Clinical and Regulatory), providing technical support as required.

Responsibilities

  • Drafting technical documentation
  • Meticulous review of customer-facing documentation (for example, instructions for use, operator manuals, labelling
  • Administration of project-specific documentation (product requirements, specifications, specification tracking)
  • Ensure all technical documentation is compliant with binx’ quality management system
  • Maintain an awareness of the regulatory and technological landscape relevant to the areas in which binx has R&D and commercial activity

Education, Experience, and Demonstrated Skills

  • BSc in an appropriate scientific discipline
  • 3-5 years experience in IVD product R&D or regulatory affairs
  • Working within a Quality Management & Regulatory framework
  • Good understanding of documentation and product literature requirements for IVDs
  • Excellent editing and proofreading capabilities
  • Working knowledge of ISO 13485:2016 or similar QMS
  • Experience in autonomously managing projects
  • Good presentation technique
  • Strong verbal & written communication
  • Working to deadlines
  • Attention to detail, well organized
  • Competent in word processing, spreadsheets, databases

Additional Information

Employees may be required to lift routine office supplies and use office equipment. The majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

binx health, Ltd. is an Equal Opportunity Employer For interested applicants, please submit resumes to careers@mybinxhealth.com