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Quality & Regulatory Specialist

1 week, 6 days ago
United Kingdom
Full-time
Mid Level
Compliance Manager
Quality Assurance and Testing
Apply Now
Vero HR

Vero HR

Vero HR is a leading HR outsourcing company offering global HR solutions. They provide a configurable, scalable blend of expert advice, services, and technology tailored to transform and support organizations across the UK, Europe, and internationally....

Professional Services
11-50
Founded 2005
View All Jobs 11

Description

  • Deliver quality and regulatory client projects focused on medical devices with software elements.
  • Educate clients on regulatory documentation requirements and the reasons behind them.
  • Create, review, and structure medical device technical documentation.
  • Support quality and design activities aligned to medical device regulations and standards.
  • Help clients compile and organise documentation into regulator-ready formats.
  • Adapt internal templates to meet specific client and product needs.
  • Lead and contribute to client meetings with clear guidance and confidence.
  • Liaise closely with software engineers, product teams, HR, and senior stakeholders.
  • Work collaboratively with colleagues to deliver practical, joined-up solutions.
  • Manage and deliver multiple client projects simultaneously in a consulting environment.

Requirements

  • Background in software-based medical devices.
  • Experience working within medical device quality management environments.
  • Experience working closely with engineers and supporting documentation development during product development.
  • Strong understanding of quality and regulatory expectations for medical devices.
  • Confident communicator able to engage with both technical engineers and senior leadership.
  • Highly organised, methodical, and detail-driven.
  • Comfortable working independently while contributing to a collaborative team.
  • Experience with medical device technical documentation is desirable.
  • ISO 13485 or other medical device standards experience is desirable.
  • Gap analysis, internal auditing, process development, AI/advanced software exposure, or client-facing consultancy experience is desirable.

Benefits

  • Salary between £45,000 and £55,000 depending on experience.
  • 28 days annual leave, including bank holidays plus your birthday off.
  • Fully remote working with quarterly in-person team events, with expenses covered.
  • Vitality Healthcare.
  • Life assurance at 4x salary.
  • Ongoing training and development, including support for further certifications.
  • Progression opportunities as the medical device and international standards offering grows.

Interested in this position?

Apply directly on the company website

Apply Now

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