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