QA/RA Manager

Overview

QA/RA Manager – Medical Devices for a London-based client. You will lead the development and operation of the Quality Management System (QMS), support IT/data security, and implement regulatory strategies to maintain compliance and enable product commercialization.

Responsibilities

• Implement and maintain the QMS, including Document Control, Non-Conformance, CAPA, and audit programs
• Ensure alignment with medical device standards and regulations: ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 60601, UK MDR 2002, EU MDR 2017/745, FDA QSR
• Manage supplier and service provider compliance
• Oversee Design Control, Risk Management, and quality metrics reporting
• Support regulatory submissions (UKCA/CE, FDA, clinical/research studies)
• Promote a strong quality culture and coordinate IT, information security, and Health & Safety activities

Qualifications

• Degree in Life Sciences, Engineering, or related field (or equivalent industrial experience)
• Proven experience managing QMS and compliance in medical devices (hardware & software)
• Strong knowledge and application of medical device standards and global regulatory frameworks
• Experience with electronic QMS software and internal auditing
• Experience contributing to regulatory submissions and interacting with notified/regulatory bodies
• Previous experience in oncology preferred
• Strong leadership, collaboration, and stakeholder management skills
• Data protection or information security experience
• Health & Safety training (e.g., IOSH Managing Safely)

Benefits

• Share options
• Private medical and dental cover
• Life and health insurance
• Lunch provided at work
• Flexible working (minimum 2 days/week in office)
• 25 days annual leave
• Bonus scheme linked to company milestones
• Opportunities for learning and professional development