Quality Assurance & Regulatory Affairs – Medical

We are recruiting for a Quality Assurance and Regulatory Affairs Manager (QARA) for a client working in the medical sector.

About this role:

This is a new position within the company and will report to the UK Operations Director, as well as reporting to the Head of QA/RA based in the United States. As the Quality Assurance and Regulatory Affairs Manager you will own the processes associated with Quality System, Regulatory Compliance and product quality at the site. These include CAPAs specific to the site, management of internal audits and external audits, quality system enhancements and process improvements, and ensuring overall site regulatory compliance. This role will work closely with other Quality Managers, Quality Engineers, and internal and external auditors based in the U.S. to ensure the company maintains a robust and compliant Quality System while continuously improving UK site operations and processes. Additionally, this role is responsible for working directly with the Quality Management Representative to act as the delegate for the Management Representative locally. This role may require 15% travel when safe and appropriate.

Specific job responsibilities include:

• Ensure the overall site activities are in compliance with the Company’s Quality System and applicable international standards / regulations, including ISO 13485, ISO 14971 and EU MDD/MDR requirements
• Partner with U.S. based Quality Managers and Quality Engineers to ensure alignment of processes and systems at the UK site
• Lead CAPA related activities at the UK site in partnership with the global CAPA coordinator
• Lead Quality representative at the UK site for internal and external audits, including Notified Body audits
• Own timely resolution of site-specific audit observations and non-conformities
• Partner with Quality Systems and Manufacturing Quality teams to ensure issue escalations and field safety corrective action decisions are made in a timely manner
• Manage UK site FSCA/FA activities including timely notifications to MHRA
• Partner with post-market quality team in the U.S. to ensure consistency in post-market process and timely closure of complaints
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to processes across the UK site
• Act as the delegate for the global Management Representative locally
• Aid in investigation of complex quality issues
• Aid in support of potential ship holds or field corrective actions

About you:

• Previous experience within the medical sector would be a distinct advantage
• Bachelor’s Degree or equivalent preferred
• Previous quality/regulatory experience required
• Significant experience in Quality or Regulatory related role
• Deep understanding of medical device Quality Management Systems and associated regulatory requirements required
• Previous experience in medical device with working knowledge of ISO 13485
• Strong investigational and problem solving skills
• Must build rapport across functional teams
• Attention to detail and timeliness are critical
• Excellent communication (verbal and written) and interpersonal skills required
• Direct exposure to regulatory body inspections and/or Notified Body audits

Package: Basic salary £60,000 + bonus Pension Scheme Dental Plan