The opportunity:

Our client is an exciting Med-tech business based in Manchester and are currently seeking a skilled Quality professional to join their team to support with the optimisation of the Quality Management System (QMS) and Regulatory processes as the approach ISO13485 readiness and FDA preparation.

The responsibilities:

As the Quality & Regulatory Associate your primary function is supporting with QA/RA documentation, design controls, Quality processes and implementation. You will need to liaise closely with internal teams and offer a pragmatic approach to managing quality and regulatory requirements within the business:

Key functions include:

• Support day-to-day operation of ISO13485 QMS
• Support with FDA 510(k) technical documentation
• Maintain Design File History and Technical documentation
• Maintain and review quality documentation, change controls and CAPA processes
• Prepare documentation for internal readiness reviews and audits
• Support and promote continuous improvement in quality processes

The ideal applicant:

This role is seeking an individual with a delivery-focused mindset and a pragmatic approach to problem solving. The right experience is beneficial, but the right attitude is essential. I would be interested to speak with people who have:

• Prior industry experience in a Quality Assurance and/or Regulatory Affairs role within the Medical Devices or Med-tech sector.
• Experience with FDA 510(k) filing would be beneficial
• Experience and strong knowledge of ISO13485 QMS
• Familiarity with Design controls and Design History Files
• Excellent communication skills and attention to detail

The offer:

Our client offers a permanent opportunity with an annual salary of £35,000-£45,000 dependent on experience.

More than that, this is an opportunity to join the business at a key stage of their development. As the company scales, our client is seeking someone who can grow with the business and broaden their own Quality and Regulatory scope.