Senior Quality Regulatory Specialist

  • Location
    Cheltenham, Gloucestershire
  • Salary
    £ 50000 - £ 60000 / Year
  • Job type
  • Industry
  • External Reference
  • Category
    Science - Quality Assurance

Adecco are pleased to be working with a Medical Device manufacturing business who are looking to hire a Quality and Regulatory Lead on a permanent basis.

Working as the sole person across QA/RA you will be responsible for all quality assurance and regulatory activities, including regulatory approvals, quality management system compliance, product quality and process improvements.
Alongside this you will work cross collaboratively with the team and wider business to provide guidance to ensure the ongoing performance, safety, and compliance of all products.

A selection of tasks will include:

  • Ensuring continued compliance of the EQMS with all relevant standards including ISO 13485 and MDSAP requirements.

  • Remaining compliant with national and international regulations, MDD, MDR, UKCA, FDA, CE marking.

  • Implementing an effective post market surveillance and CAPA process

  • Leading the registration of companies products into global markets liaising with regulatory bodies

  • Perform internal and supplier audits, ensuring suppliers remain of high standard to the business

  • Monitoring and reporting on quality objectives and Key Performance Indicators

What's needed to succeed?

The ideal hire will be someone with a demonstrated history of working in the Medical Device industry with at least class ii exposure and who can expand beyond the scope of assigned responsibilities to gain proficiency in new areas.

You will work independently to solve problems, have a positive and collaborative working style and communicate with transparency regarding KPI tracking as well as ongoing/planned projects.

You have a strong interest and understanding of the products, customer and user needs and business requirements.

If you are interested in learning more please apply or send your CV

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder