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Quality & Regulatory Manager

Real Staffing
Job LocationCambridge
EducationNot Mentioned
Salary£50,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

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.Principal Responsibilities

  • Support the maintenance and development of the companys quality management system
  • Manage the companys quality management system
  • Manage the companys design and development document management system.
  • Work with development team to facilitate compliance of companys 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 companys quality management system
  • Other responsibilities as defined for the role in the companys 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 www.realstaffing.comReal 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 | OC387148 England and Wales Required skills
  • Audit
  • Risk Management
  • Software
  • quality assurance
  • ISO13485
  • medical device
  • regulatory affairs
  • SAMAD

    • Keyskills :
    Audit Risk Management Software quality assurance ISO13485 medical device regulaty affairs SAMAD

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