Radisens Diagnostics is expanding its product and process development teams to extend the test menu offering on its proprietary diagnostic platform. The successful candidates will demonstrate a mix of skills, with industrial experience in a relevant in-vitro diagnostics (IVD) product development or process development environment a distinct advantage.

Available Vacancies:

  1. Senior Quality/Regulatory Engineer
  2. Development Scientists – Clinical Chemistry

 


Senior Quality/Regulatory Engineer

Job Functions

  • Become a leading member of Radisens’ team developing the next generation of point-of-care in-vitro diagnostic platforms,
  • Drive and Implement the Design Control process for Radisens’ innovative platform in accordance with 21 CFR Part 800 and ISO13485,
  • Review, update and manage the existing Design Control System within QMS,
  • Establish and maintain Design History Files (DHF) and carry out Risk Management,
  • Work closely with Radisens’ multidisciplinary teams of clinical scientists, engineers, software developers in a highly innovative and interactive environment.

Required Skills and Experience

  • Primary/Higher Degree in relevant discipline with 5+ years relevant industrial experience,
  • Experience in Design Control within the In Vitro Diagnostics (IVD) Sector in a senior position,
  • Experience of the following is essential:
    • 21 CFR Part 800, ISO13485,
    • Writing and maintenance of Design History Files,
    • Risk Management.
  • Experience of clinical chemistries, point of care technology, instrumentation,
  • Self-starter with demonstrated ability to work in a multi-disciplinary and deadline-driven environment with an analytical approach to problem-solving,
  • Experience of ISO requirements, GMP guidelines and regulatory approvals,
  • Supplier Management,
  • Experience with product development cycle and manufacturing scale-up processes,
  • Excellent oral and written communication skills,
  • This role may require national and/or international travel.

Radisens Diagnostics Ltd. is an equal opportunities employer.

Candidates should apply online, using reference QARA-S01. Strictly no agencies.

 

Development Scientists – Clinical Chemistry

Job Functions

  • Become a leading member of Radisens’ Assay Development team, defining and implementing the next generation of portable medical diagnostic architectures,
  • Drive the design and development of Radisens’ clinical chemistry assays,
  • Document research summaries and results, SOP’s and invention disclosures,
  • Follow design, verification and quality standards and best practises necessary for production test and regulatory approval,
  • Work closely with Radisens’ multi-disciplinary teams.

Required Skills and Experience

  • Primary degree in relevant discipline (Life Science/Biochemistry, or equivalent),
  • 2+ years relevant development experience, ideally within industry,
  • Ability to work on own initiative and as part of a team,
  • Strong interest in in vitro diagnostic technology,
  • Experience of several of the following is highly desirable:
    • Point of care test development,
    • Clinical chemistry, e.g. lipid chemistries, etc.
    • Formulation of clinical chemistry tests,
    • Experience with clinical chemistry analyzers,
    • Statistical methods as they relate to clinical assays,
    • Excellent pipetting and general laboratory skills,
    • Understanding of enzyme kinetics and inhibition.
  • Experience with ISO requirements and GMP guidelines, and regulatory approvals.
  • Experience with design control and manufacturing scale-up processes,
  • Strong analytical/problem solving skills, and product development background,
  • Willingness to work in a multidisciplinary team environment,
  • Flexibility to take advantage of opportunities within a high growth company,
  • Excellent oral and written communication skills,
  • This role may require national and/or international travel.

Radisens Diagnostics Ltd. is an equal opportunities employer.

Candidates should apply online, using reference ASSAY-D04. Strictly no agencies.