Quality Assurance Administrator

Role Purpose:

To provide administrative support to the Quality Assurance and Regulatory Affairs function, ensuring smooth coordination of documentation, compliance activities, and audit preparation. The role is designed to complement the work of an ad hoc QA/RA Manager and support regulatory compliance under UK MDR and EU MDR frameworks.

Key Responsibilities:

• Maintain and update quality documentation, SOPs, and compliance records in line with ISO 13485:2016.
• Assist in compiling and organizing technical files and QMS documentation.
• Support coordination of audits (1st, 2nd, and 3rd party), including scheduling and document preparation.
• Track and manage CAPAs, complaints, and vigilance reports.
• Assist in preparing documentation for MHRA communications and regulatory submissions.
• Coordinate Management Review meetings and follow up on action items.
• Liaise with internal departments to ensure QA processes are followed and documented.
• Provide administrative support for risk management and PMS activities under ISO 14971:2019.

Essential Skills & Experience:

• Previous experience in an administrative role within a regulated industry (medical devices, pharma, or healthcare).
• Working knowledge of QA principles and ISO 13485:2016.
• Familiarity with regulatory documentation and technical file management.
• Strong organisational skills and attention to detail.
• Proficient in Microsoft Office Suite and document control systems.
• Ability to work independently and manage multiple priorities.

Desirable Qualifications & Experience:

• Exposure to EU MDR 2017/745 and UK MDR 2002.
• Experience supporting audits or inspections (e.g., MHRA, Notified Bodies).
• Understanding of medical device classifications and regulatory pathways.
• Familiarity with infusion devices or similar product categories.