QARA Manager

Cure Talent is delighted to be exclusively partnered with an innovative early-stage Medical Device company specialising in Female Health Diagnostics. Their goal is to pioneer advancements in early detection and treatment options for gynaecological cancers, developing cutting-edge technologies and healthcare solutions that enhance outcomes and save lives. This is a hybrid role offering flexible home and site working arrangements. As they embark on this journey, we have an exciting opportunity for a QARA Manager to play a pivotal role in implementing and driving the development & maintenance of their Quality Management System (QMS). In this brand new role you will support in achieving UKCA Marking and will also support the transition towards CE Marking and FDA approval, working closely with internal teams to ensure regulatory compliance. To be successful in this role we are looking for an experienced Medical Device Quality Assurance professional with proven experience in the implementation and subsequent management and development of QMS. You will have experience of working within a smaller, growing organisation and understand the nuances of the early-stage development process and ideally have experience in supplier selection, management and auditing. A 13485 Lead Auditor qualification is highly advantageous for this role. Responsibilities:

• Lead the implementation, management, and continuous improvement of the Quality Management System
• Oversee the UKCA marking process, ensuring readiness for audits and regulatory milestones
• Develop and manage supplier selection and auditing processes
• Support regulatory strategies including preparation for CE Marking and future FDA submissions
• Ensure compliance with relevant regulations and support post-market activities

Qualifications:

• Proven experience in a senior QA or QARA role within Medical Devices
• Experience & knowledge of the implementation of a 13485 QMS
• Strong knowledge of UKCA and CE marking processes (understanding of FDA regulations is highly advantageous)
• Experience in supplier management and auditing
• Knowledge and experience of IVD’s and the subsequent regulations is highly advantageous

If you are a driven and innovative professional ready to make a significant impact in a growing company, we would love to hear from you. Get in touch with Kris Holmes at Cure Talent today

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