Head of Quality & Regulatory

This Head of Quality and Regulatory role is a critical position within Group globally. It's a highly regulated industry, making quality and compliance the number one focus in everything our client does. Sitting within the category team, this individual is responsible for a team covering our manufacturing and external suppliers on all aspects of regulatory and quality. .

The role included but is not limited to:

1. QMS - Responsible for the development and ongoing maintenance of robust quality management systems ensuring the company's statutory and contractual duties are fulfilled and exceeded. Ensure systems and services are monitored and reviewed to continually improve quality standards.

2. Provides clear, constructive regulatory advice and guidance to the organisation and is responsible for the design and execution of all regulatory strategy

3. Support and represent the Quality & Regulatory discipline in new product introduction and product development projects to ensure all aspects of quality, testing and certification are undertaken correctly.

4. Oversight of internal and external compliance activities, ensure the organisation is compliant and prepared for audits

5. Undertake due diligence to validate and approve new suppliers and manage the ongoing requirement and audits

6. ISO - Maintaining current and creating new ISO documentation for each site and increasing scope of certification as necessary.

7. Manage the relationships with the key Certification Bodies (BSI, SATRA, SGS, INSPEC etc.) for the ISO Management System Audits, Product Testing and Certification

8. Responsible for the internal lab and ensuring the in-house compliance testing has been completed on an ongoing basis, to ensure product is still meeting the standard. Working closely with Production to ensure all manufactured product is compliant

9. Responsibility for all products coming out of UK manufacturing sites as well as products which are sourced.

10. Responsible for collating all data for technical files including ensuring clinical evaluations are processed, risk assessments completed as well as all other items.

11. Collating data for the management review for ISO13485

12. Involvement in customer complaints relating to non-conforming product and Ensuring customer complaints are dealt with in a timely manner and manage the corrective action process

13. Provide escalation, weekly updates and reports to their line manager and wider management as required

14. Takes personal responsibility for the notification and tracking of Regulatory and quality activities and related database entry/data accuracy.

15. Highlights any updates to regulatory requirements to senior management

16. Maintaining the calibration register for testing and measuring equipment