Regulatory and Compliance Specialist

Job Opportunity: Regulatory & Quality Specialist

Company Overview
Our client is the leading manufacturer in the UK for Medical Couches, Patient Trolleys, and Ergonomic Seating. Their products are designed and produced at headquarters in East Anglia. They take pride in their innovative and high-quality designs that enhance patient care in the global healthcare sector.

Key Responsibilities
This role aims to support the department through various activities, including:

• Assisting the design team with the preparation or revision of documentation to ensure regulatory compliance.
• Leading and authoring essential documents for the technical file.
• Advising the marketing team on regulatory strategy development and execution for global product registrations.
• Creating procedures and templates to facilitate the regulatory function.
• Providing support to the QA function as needed.

Reporting Structure
You will report to the Head of Design, Quality, and Regulatory Compliance. Your duties will encompass, but are not limited to:

• EU MDR & UK MDR Compliance
• Global Regulatory Submissions
• Development of Regulatory Strategies, including test plans
• Creation and remediation of Technical Files
• Global Regulatory Intelligence
• Compliance with Labelling & Packaging standards
• Support for CAPA, SOPs, and Internal Audits
• Development of ISO 13485 QMS

Qualifications, Skills, and Experience

Essential:

• Strong understanding of EU/UK MDR.
• Ability to author and/or lead the development of key documents within a technical file (e.g., CER, RMF, PMCF, Usability).
• Familiarity with IFU, labelling, and packaging requirements.
• Experience in leading or contributing to global product registrations.
• Good knowledge of ISO 13485 and ISO 14971.
• Excellent communication skills, both internally and externally.

Desirable:

• Understanding of the NHS supply chain quotation/registration process.
• Knowledge of the following IEC standards: 60601-1, 60601-1-2, 60601-2-52, 62304, 62366-1.
• Familiarity with MEDDEV 2.7.1 Clinical evaluation.