Quality Assurance Assistant

Our client is an innovative and growing organisation operating within the digital health and medical technology sector, developing advanced healthcare solutions that improve patient outcomes worldwide.

They are seeking a highly organised Quality & Regulatory Coordinator to support the day-to-day operation of Quality Management Systems (QMS), Regulatory Affairs activities, compliance programmes, and information security initiatives within a highly regulated environment.

Responsibilities:

• Coordinate day-to-day Quality Management System (QMS) activities.
• Manage document control, version management, and review schedules.
• Maintain quality records, document registers, and compliance trackers.
• Coordinate training records and mandatory training requirements.
• Support the implementation and maintenance of electronic Quality Management Systems (eQMS).
• Monitor CAPAs, change controls, and engineering change requests.
• Produce quality metrics, reports, and compliance dashboards.
• Coordinate regulatory submissions and supporting documentation.
• Maintain regulatory databases, registrations, and submission trackers.
• Support communications and documentation requests from external regulatory stakeholders.
• Assist with the planning and coordination of internal and external audits.
• Support Information Security Management System (ISMS) activities, including document control, incident tracking, audits, and compliance monitoring.
• Organise departmental meetings and prepare meeting documentation and minutes.
• Maintain departmental dashboards, trackers, and performance records.
• Support continuous improvement initiatives and quality projects.
• Act as a key point of contact for quality and regulatory document requests across the business.

Essential Requirements:

• Degree qualified (or equivalent experience) in Science, Engineering, Life Sciences, or a related discipline.
• Experience working within a regulated industry such as medical devices, pharmaceuticals, biotechnology, healthcare, diagnostics, or manufacturing.
• Strong organisational and administrative skills.
• Excellent attention to detail.
• Strong written communication skills.
• Ability to manage multiple priorities and deadlines effectively.
• Proficient in Microsoft Office applications.

Desirable Requirements:

• Experience working with ISO 13485 and/or ISO 27001 standards.
• Experience using electronic Quality Management Systems (eQMS).
• Previous experience within the medical device or healthcare technology sector.

What's on Offer?

• £28,000 - £32,000 salary
• Hybrid and flexible working arrangements (mostly remote)
• Exposure to Quality, Regulatory, and Information Security functions
• Career development opportunities within a growing organisation
• Supportive and collaborative working environment