Job DescriptionWe are recruiting for a Quality Assurance and Regulatory Affairs Manager (QARA) for a client working in the medical sector.
Title: Quality Assurance and Regulatory Affairs Manager (QARA)Sector: Medical Location: Bracknell areaAbout 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 requirementsPartner with U.S. based Quality Managers and Quality Engineers to ensure alignment of processes and systems at the UK siteLead CAPA related activities at the UK site in partnership with the global CAPA coordinatorLead Quality representative at the UK site for internal and external audits, including Notified Body auditsOwn timely resolution of site-specific audit observations and non-conformitiesPartner with Quality Systems and Manufacturing Quality teams to ensure issue escalations and field safety corrective action decisions are made in a timely mannerManage UK site FSCA/FA activities including timely notifications to MHRAPartner with post-market quality team in the U.S. to ensure consistency in post-market process and timely closure of complaintsEngages in continuous improvement activities by identifying opportunities and recommending improvements to processes across the UK siteAct as the delegate for the global Management Representative locallyAid in investigation of complex quality issuesAid in support of potential ship holds or field corrective actions About you: Previous experience within the medical sector would be a distinct advantageBachelor's Degree or equivalent preferredPrevious quality/regulatory experience requiredSignificant experience in Quality or Regulatory related roleDeep understanding of medical device Quality Management Systems and associated regulatory requirements required Previous experience in medical device with working knowledge of ISO 13485Strong investigational and problem solving skillsMust build rapport across functional teamsAttention to detail and timeliness are criticalExcellent communication (verbal and written) and interpersonal skills requiredDirect exposure to regulatory body inspections and/or Notified Body audits Package:Basic salary £60,000 + bonusPension SchemeDental PlanQuality Assurance and Regulatory Affairs, Quality Assurance / (QARA) Regulatory Affairs Manager Manager, compliance