Quality & Regulatory Officer

Role Overview

The Quality & Regulatory Officer will oversee daily operations of the company’s Quality Management System (QMS), Environmental Management System (EMS), and ensure adherence to regulatory standards. This position is responsible for managing supplier documentation, complaint and CAPA administration, training records, audit preparations, as well as compliance for commercial tenders.

Primary Responsibilities

• Maintain controlled documents within QMS and EMS, including creation, revision, approval, and removal of obsolete documents; manage document registers and ensure access to up-to-date materials.
• Oversee supplier compliance documentation such as ISO and CE certificates, declarations of conformity, product technical summaries, EU representative details, and supplier agreements, ensuring tracking of expiry dates and following up on renewals.
• Manage CAPA and complaint records by logging and tracking issues, supporting investigations, maintaining evidence, escalating regulatory concerns, and assisting with trend analyses.
• Maintain comprehensive training records and matrices, monitor completion of mandatory training, and support EMS awareness training for environmental compliance.
• Assist with audit processes, including preparation of evidence and records for internal, external, supplier, and certification audits such as ISO 13485, ISO 14001, and MDR-related audits; track audit findings and corrective actions.
• Manage EMS records, objectives, environmental performance data, KPIs, and compliance with legal obligations; assist with environmental incident reporting and sustainability initiatives.
• Support commercial tender documentation by maintaining standardized document libraries, assisting with questionnaire completion, and coordinating compliance information across departments.
• Support management with quality, environmental, and compliance data for reviews, risk management documentation, recall administration, and continuous process improvements within QMS, EMS, and tender functions.

Reporting and Relationships

The position reports to Senior Management and works closely with the Commercial/Tender Lead. Collaborative interactions include Managing Director, Customer Service, Warehouse/Operations, suppliers, certification bodies, regulatory consultants, external auditors, and environmental service providers.

Required Skills & Experience

• Strong attention to detail and record-keeping abilities.
• Proficient written communication skills and competency with Microsoft Office and document management systems.
• Capability to manage deadlines, track actions, and maintain compliance records.
• Experience in regulated environments such as medical devices, healthcare, pharmaceuticals, or laboratories.
• Knowledge of ISO standards including 13485, 9001, 14001, as well as MDR and relevant regulatory requirements.
• Familiarity with regulatory supplier documentation and EMS sustainability tracking.
• Comfort engaging with suppliers, customers, auditors, and internal teams.

Desirable Qualifications

• Previous experience in quality, regulatory, compliance, or tender support roles.
• Background in ISO 13485-certified organizations and ISO 14001 environmental management.
• Experience with public sector tender processes and procurement documentation.