Document Control Specialist - In Vitro Diagnostics

Document Control Specialist - In Vitro Diagnostics Location: London (fully site-based) Duration: 12 Month Contract Pay: Competitive Rate Proclinical is partnered with a regulated healthcare organisation operating within medical and in-vitro diagnostics. Due to continued expansion they are looking to hire a Document Control Specialist to join their Quality team at their London offices. This role will be responsible for the day?to?day management of Quality Management System (QMS) documentation, ensuring all controlled documents are compliant with ISO 13485 and FDA 21 CFR Part 820 requirements. Key Responsibilities of the Document Control Specialist Manage and maintain controlled QMS documentation in line with internal procedures Coordinate document creation, review, approval and distribution workflows Monitor document revisions and manage document change orders Maintain an accurate and up?to?date electronic document management system Support global QMS integration and continuous improvement activities Deliver document control and quality system training as required Liaise with internal teams and external vendors on documentation matters Prepare reports and support audit readiness activities Requirements for the Document Control Specialist Previous experience in Document Control / Quality Documentation within a regulated environment Working knowledge of ISO 13485:2016 and 21 CFR Part 820 Experience using electronic document management systems (eDMS) Strong attention to detail and excellent organisational skills Ability to work independently and collaborate across teams What's on offer Opportunity to work within a growing, regulated healthcare organisation Exposure to global quality systems and regulatory standards Competitive salary and benefits package If you are having difficulty in applying or if you have any questions, please contact Neil Walton at (url removed)