Part-Time QA / Regulatory Affairs Manager, GeneFirst Ltd, Oxford, UK | GenomeWeb

Part-Time QA / Regulatory Affairs Manager, GeneFirst Ltd, Oxford, UK

Organization
GeneFirst
Job Location
Building E5 Culham Science Centre
Abingdon
Oxford
Oxfordshire
OX14 3DB
United Kingdom
Job Description

GeneFirst develops novel diagnostic methods based on real-time PCR and next generation sequencing. We require a part-time (hours by negotiation) QA / Regulatory Affairs Manager to join the dynamic and friendly team based at Culham Science Centre, Oxford. The role will involve managing all aspects of quality assurance and regulatory compliance as GeneFirst moves from the development phase into commercial production.

Requirements:

  • A technical background, at least to degree level, in molecular biology, biotechnology or similar discipline.

  • Proven track record in Quality Assurance.

  • Experience of working to ISO13485.

  • Experience in IVD or medical device CE marking (including the preparation of technical files and management of performance evaluation studies).

  • Familiarity with the regulatory landscape for IVDs in Europe, US and elsewhere.

  • Experience in quality assurance for manufacturing (either in-house or by contractors).

  • Familiarity with the design and management of stability studies.

  • Experience in conducting internal audits.

  • Knowledge of real-time PCR and / or next generation sequencing desirable.

  • Experience in preparation of instructions for use and commissioning of packaging desirable.

  • Experience in the training of others desirable.

The successful applicant should be enthusiastic about working on molecular diagnostics and be keen to learn and develop their skills within the company. GeneFirst is a fast growing company and we seek to recruit staff with the potential to grow with us.

How to Apply

Please apply in writing, including your cover letter and CV to karen.smiter@genefirst.com.

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