Astute People Ltd

Quality and Regulatory Affairs Manager

£50k - £70k Basic, bonus, car, BUPA, relocation package

Newquay/Cornwall

Astute Technical are recruiting for a Quality and Regulatory Affairs Manager for a client who are a leader in the provision of separation and purification solutions to industries including biotech, oil and gas, laboratory and chemicals.

As Quality and Regulatory Affairs Manager, your duties will include:

• Provide leadership and technical expertise to site & Business Unit in the implementation of relevant Quality Systems, improvements and production requirements. This includes licensing partners as well as suppliers.
• Maintain QMS to ISO 9001, ISO 13485, FDA 21 CFR Part 820and other standards in accordance with BU specific requirements, including document control and record retention.
• Data analysis and implementation of continuous improvement plans to meet agreed KPI's

To be considered for the Quality and Regulatory Affairs Manager role, candidates should have:-

- Proven experience in Quality Management and Medical Devices preferably within an international FMCG environment.

- Proven track record of delivering Quality change with experience of World Class Quality techniques.

- Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO9001, FDA 21 CFR Part 820, and ISO 13485

As a Quality and Regulatory Affairs Manager with our client, you will receive:-

• Competitive salary of £50k - £70k Basic
• Company Bonus scheme
• 25 days Holiday
• BUPA Healthcare

Application Process:

Applying for this exciting opportunity could not be easier, simply email your up to date CV and covering letter to Simon Cheung on scheung@astutetechnical,co.uk or 023 93 911 007