Quality Assurance and Regulatory Affairs Manager
Waltham Abbey, Essex, South East, United Kingdom
Hybrid / WFH Options
Hybrid / WFH Options
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as minimum) As a Quality and Regulatory Affairs Manager at our client, you will play a key role in maintaining and developing their Business Management Systems and ensuring that all their in-vitro diagnostic medical devices meet stringent UK, EU, and international regulatory requirements. Your work will be central … you will take ownership of their Business System Manuals and Technical Documentation, ensuring they remain robust, up to date, and audit ready. As the Management Representative for ISO 13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams … to embed quality and regulatory best practices into everything they do. Whether maintaining technical documentation, leading management reviews, or liaising with regulatory bodies, you will play a vital part in ensuring that our client continues to meet and exceed regulatory expectations while fostering a culture of accountability and excellence. More ❯
Employment Type: Permanent
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