QA/RA Manager – Medical Devices
We are seeking an enthusiastic QA/RA Manager with a strong background in medical devices and regulatory compliance to support 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.
Key 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
Requirements:
* 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
Desirable:
* Data protection or information security experience
* Health & Safety training (e.g., IOSH Managing Safely)
Benefits:
* Share options
* Private medical and dental cover
* 5% employer pension contribution
* 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
If this position could be of interest apply, or reach out on:
✉ lcattcamfield@barringtonjames.com
☎ +44 (0) 1293 776644