Quality Assurance / Regulatory Affairs Manager

Quality Assurance / Regulatory Affairs Manager
Location: Office Based (Essex) + 20% Travel
Full time, permanent
Package: up-to £45k + benefits (Private medical & Pension)
Direct Reports: 6

Our Client, a global medical device company is looking to recruit an experienced Quality Assurance and Regulatory Affairs Manager from the medical devices sector.

As Quality Assurance and Regulatory Affairs Manager you will support all the Managing Directors within the Group of companies ensuring that the companies maintain regulatory approvals.

You will also lead and manage your team of six ensuring that the necessary documentation for the approvals for sales of medical devices in the UK and other countries is prepared and maintained

Quality Assurance and Regulatory Affairs Manager Key Tasks
* Ensure the QA Department is effective.
* Keeping the General Manager and other senior managers informed of the status of the quality system and product approvals.
* Ensure internal quality audits are planned and carried out.
* Ensure that customer complaints are investigated and corrective and preventative action(s) are taken where necessary.
* Ensure that the quality audit system is effective and suitable.
* Liaise with external quality agencies and approval bodies to maintain company quality approvals and manage the introduction of other approvals as required.
* Maintain and develop the company quality manual and procedures.
* Promote and develop quality awareness and improvement activities within all areas of the company.
* Measure and analyse quality costs and recommend corrective actions.
* Provide support and guidance on regulatory affairs to other companies within the Group.
* Co-ordination of product approval through external agencies.
* Summarise the monthly reports that provide status of quality levels, customer complaints, areas that require progressing and other relevant issues.
* Assist in the co-ordination of product approvals.

Quality Assurance and Regulatory Affairs Manager: Skills & Experience
* A comprehensive knowledge of Quality standards and the regulatory requirements of UK, EU, USA, Canada and others as required.
* Self-motivated but able to work as part of a team.
* The ability to communicate at all levels
* Use of computers for data analysis and communication.
* Regulatory knowledge and advice. (ISO13485 & MDD)
* Ability to analyse and implement improvements.
* Understanding of financial processes & budgetary controls.
* Presentation skills.
* Input to strategic planning.
* Line management experience

On offer is a competitive salary of up-to £54,000+ benefits.

To find out more about this opportunity please apply today or call for a confidential chat.

Keywords: Medical devices, Regulatory Affairs, Quality Assurance