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. Quality/Regulatory Affairs (QA/RA) Manager

 


Quality/Regulatory Affairs (QA/RA) Manager

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 FDA 21 CFR Part 800, ISO 13485 and ISO 14971,
  • 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 and Quality Management within the In Vitro Diagnostics (IVD) Sector in a senior position,
  • Knowledge of Corrective and Preventive Action (CAPA) processes and implementation,
  • Knowledge of Good Document Practise (GDP) and Good Manufacturing Practise (GMP) requirements,
  • Experience of the following is essential:
    • FDA 21 CFR Part 800, ISO 13485,
    • Writing and maintenance of Design History Files,
    • Risk Management in line with the requirements of ISO 14971.
  • 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 approval processes,
  • 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.

 

Radisens Diagnostics Ltd. is an equal opportunities employer.

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