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Quality and Regulatory Affairs Manager - Hart Biologicals

Posted: 26 July 2017

Closing: 31 August 2017


An opportunity for a Quality and Regulatory Affairs officer looking to progress their career has become available to work with Hart Biologicals Ltd,  a growing and award winning Medical Device manufacturer in the North-East.

Reporting to the Managing Director, this is a hands-on role and you will be working as part of a team to ensure quality and regulatory standards are met for their innovative range of products.
Using your knowledge of ISO 13485, you will be expected to collaborate closely with your colleagues to assist with Quality and Regulatory activities to maintain an appropriate quality environment.

The role and responsibilities:
• Maintenance and improvement of the existing ISO 13485 Quality System.
• Hosting internal Audits and liaising with notified bodies and other external regulatory bodies.
• Identify and drive improvements to the QMS in line with European and US FDA requirements.
• Help with the compilation and update of Technical Files.
Experience and Qualifications:
The ideal candidate should be educated to degree level or equivalent and should have demonstrable experience of:
• Experience in the Medical Device or Healthcare industry
• Auditor in an ISO 13485 manufacturing environment
• Developed and implemented ISO 13485 procedures.
• Experience of process validation, root cause analysis, NCR’s and internal and external audits.
• Previous experience of Technical Files and FDA Regulatory Requirements will be an advantage.
• Knowledge of Compliance Control (electronic, cloud based Quality Management System) would be an advantage but is not essential.
On Offer:
• Competitive salary
• 23 days of annual leave + Bank Holidays
• Health insurance scheme.
• Company Pension scheme contribution.

Working hours: Monday to Thursday 8.00am to 4.30pm and Friday 8.00am to 2.00pm

Applications:
If you are interested in this role, please email or mail a copy of your CV to Elizabeth Sullivan at Elizabeth.sullivan@hartbio.co.uk . For more information, please call 01429 271100.