Quality and Regulatory Affairs Manager

  • Location

    St. Columb, Cornwall

  • Sector:


  • Job type:


  • Salary:

    £50000 - £70000 per annum

  • Contact:

    Sara Nash

  • Email:


  • Job ref:


  • Published:

    21 days ago

  • Expiry date:


  • Startdate:


Quality and Regulatory Affairs Manager
£50-70k Depending on experience + bonus, car allowance, BUPA healthcare and relocation package if required

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 up to £63k Basic
  • Company Bonus scheme
  • 25 days Holiday
  • BUPA Healthcare for you and your dependents

Application Process:
Applying for this exciting opportunity could not be easier, simply call Simon Cheung on 023 93 911 007 or email your CV and cover letter to scheung@astuetechnical.co.uk

Astute Technical Recruitment Limited are acting as an employment agency in relation to this vacancy. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We encourage applications from individuals from all backgrounds but candidates must be able to demonstrate their ability to work in the UK and Europe. Astute is also committed to the government's Disability Confident Employer initiative. We endeavour to get back to everyone, however, if you have not heard anything after 7 days, please consider your application unsuccessful.

Become part of something great

  • I have received nothing but the heartiest welcome into the Business. Not your normal recruitment agency. Firstly, you receive thorough training. Instantly you get the welcoming atmosphere and there is great team morale. Management listens, Colleagues listen and my opinion and any offering I contribute, I feel is valued and taken seriously. I really enjoy the level of support I receive as a newbie to both Recruitment and the world of Technical and I genuinely feel valued. I would highly recommend and already have to many of my contacts!

  • A friendly environment that takes work seriously. Everyone at Astute seems to very much enjoy being here and that reflects on the atmosphere in such a positive way. No one ever seems to have an issue with lending a helping hand when it is needed. The way that the staff on the floor are very focused and hardworking spurs you on to be the same. The saying "Work hard, play hard" could not apply more to the lovely bunch I have the pleasure of working with. I really feel as though I have fitted in well at Astute.