Quality and Regulatory Manager

Southampton | £65,000 per annum

Job Function: Quality Assurance
Industry Sector: Biotech, Science and Pharmaceutical

Quality and Regulatory Manager
Southampton, Hampshire

The Organisation 

Our client is a leading provider of RT PCR solutions. They have thousands of happy customers based across the globe and have a real ambition to drive their business forward and achieve even more.

They are currently looking for a Quality and Regulatory Manager to join their team and oversee their quality activities. 

The Benefits

- Salary of £65,000 per annum
- Car allowance (10% of salary)
- Healthcare
- Pension scheme
- Life assurance
- 25 days’ holiday per annum

If you are an experienced quality professional with knowledge of ISO 9001, ISO 13485 and 21 CFR Part 820, this is an exciting opportunity to play a key role in the ongoing success of a leading business. 

Operating at the cutting-edge of the medical device sector, our client is an innovator in every sense of the word. From the products that they make to the people they employ, innovation runs through the heart of the business. 

So, if you want to take on a new challenge with a pioneering, technical business and ensure that quality and compliance standards are maintained to an exceptional level, this is the role for you. 

The Role

As the Quality and Regulatory Manager, you will ensure that our client’s Southampton site complies with all quality and regulatory requirements. 

Specifically, you will manage the quality and regulatory compliance requirements for the design, manufacture, sale and global distribution of products.

Your role will involve: 

- Managing the QA and QC team 
- Supporting regulatory and customer audits 
- Overseeing the transfer of manufacturing activities to sub-contractors 
- Managing our client’s key supplier base from a quality perspective 
- Taking responsibility for the site’s electronic quality management system 
- Reviewing and approving technical, regulatory and QMS documentation

About You

To be considered as a Quality and Regulatory Manager, you will need: 

- At least five years’ experience as a Quality Manager in a diagnostic environment 
- Experience with, and knowledge of, the current requirements for ISO 9001, ISO 13485 and 21 CFR Part 820
- Previous experience of conducting process validation studies
- Experience of managing suppliers and sub-contractors from a quality perspective
- Knowledge of molecular diagnostics, qPCR technology and applications
- An understanding of the key regulations for in vitro diagnostic devices, IVDD and IVDR
- People management skills 
- To be a qualified internal auditor 

Other companies may call this role Quality Assurance Manager, Regulatory Assurance Manager, QA Manager, or Regulatory Compliance Manager.

Our client would be eager to hear from you if you have experience as a Quality Manager, Internal Auditor, Certified Internal Auditor, or Compliance Manager.

Webrecruit and our clients are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be. 

So, if you are seeking your next step as a Quality and Regulatory Manager, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency. 

Working hours: 37.5 hours per week