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)