In Vitro Diagnostic Specialist

2 days ago


Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time
Join Our Team

We're a dynamic and innovative company, dedicated to improving patient outcomes through cutting-edge technology. As a MedTech Product Developer, you'll play a crucial role in driving project success and delivering high-quality products.

You'll be responsible for developing, optimizing, and validating in vitro diagnostic assays, while collaborating with our Product Development and Clinical Teams. Your expertise will be essential in ensuring quality and regulatory compliance, as well as managing lab space and documentation within our ISO 13485 quality management system.

Key Responsibilities:
  • Develop and optimize lateral flow assays, ensuring quality and regulatory compliance
  • Manage lab space and documentation within our ISO 13485 quality management system
  • Collaborate with clinicians, patients, and engineering partners to design and deliver products
  • Contribute to project management, including working with CROs and resolving technical issues
Requirements:
  • Assay development experience in the in vitro diagnostic space
  • Understanding of ISO 13485, IVDR, and FDA regulations
  • Strong project management skills, with ability to prioritize tasks and meet deadlines
What We Offer:
  • Competitive salary: £65,000 - £85,000 per annum
  • Hybrid working arrangement, with flexibility to work from home or our office space
  • Generous holiday allowance, plus bank holidays and additional days off for every two years of service
  • Pension scheme with employer contributions
  • Health insurance, dental coverage, and wellbeing engagement program


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