Our client are a boutique medical device and digital health company looking to transform the Surgical world via their unique products and platform. Regulated as a medical device the product is truly groundbreaking and disruptive. As they grow and look to grow their market share they have a requirement for a Quality & Regulatory Manager to join the company.
Support the maintenance and development of the company's quality management system
Manage the company's quality management system
Manage the company's design and development document management system.
Work with development team to facilitate compliance of company's design and development control system
Preparation and review of regulatory submission documentation.
Commercial product disposition in all approved territories
Reporting to senior management on the performance of the company's quality management system
Other responsibilities as defined for the role in the company's quality management system procedures and / or project related documents.Profile
Qualification in relevant scientific discipline
Proven ability to write procedural documents
Some experience in regulated medical device quality management systems
Some experience in regulated medical device software development lifecycle processes (preferred)
Qualified ISO 13485 internal auditor (preferred)
Proficient with Microsoft office, Adobe and similar computer applications
Ability to communicate regulatory and quality assurance principles
Self-starter with good interpersonal skills and happy to work without direct supervision
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales
Quality Management Systems