Quality Assurance & Regulatory Affairs (QARA) Manager

Job Ref: J31743
Sector: Science
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 22 May 2019
  • Cambridge, Cambridgeshire, England, UK 1 Riverside, Granta Park, Cambridge, CM2 6AD Cambridge Cambridgeshire UK CM2 6AD
  • £40,000 - £50,000 per Annum
    ANNUM
  • Dominic Cappell
  • 01223 607 857
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Quality Assurance & Regulatory Affairs Manager

A new and exciting opportunity has emerged in an up-and-coming medical device company based in Cambridge UK.

The Quality Assurance & Regulatory Affairs Manager will be responsible for the company's QMS, operating procedures and risk management. The successful candidate will also contribute to the R&D and manufacturing team.

Location: Cambridge, UK

Salary: £40,000 - £50,000

Permanent

Start - ASAP

Main Responsibilities:

  • Manage Regulatory Compliance
  • Manage and develop QMS
  • Review and manage SOPs
  • Manage manufacturing and procurement from a quality perspective
  • Manage and update QA systems
  • Drive risk management initiatives
  • Manage employee QMS training
  • Manage internal audit programme and host regulatory inspection
  • Contribute to the R&D process

Person specification:Essential:

  • BSc / MSc / PhD degree or equivalent in Molecular Biology or similar field
  • Experience in an Medical Device or In vitro Diagnostics (IVD) environment
  • ISO13485, IVDD 98/79/EC, MDD 93/42/EEC, GCLP, FDA Reg: CFR part 820 experience
  • Strong GCP knowledge of clinical trials regulations

Desirable:

  • Knowledge and Experience of medical device manufacturing and supply chain requirement
  • Expirence in CE marking

If this represents an opportunity you would be interested in and your CV reflects the key areas mentioned above then please apply now by attaching your CV in MS Word format.

Alternatively, for more information on this role, please contact Dominic Cappell Dominic.Cappell@srg.co.uk / 01223 607857.

SRG
21/06/2019 09:14:42
GBP 40000.00 40000.00