We're looking for an enthusiastic and self‑motivated Quality & Regulatory Specialist to join our client's expanding Medical Device and International Standards team. You'll support a diverse portfolio of clients developing medical devices with a strong software focus, helping them understand regulatory expectations and create the documentation and quality foundations required for market entry.
If you enjoy working closely with key stakeholders for companies developing medical technologies, translating complex requirements into practical solutions, and genuinely helping people understand why quality matters, this could be the perfect role for you.
About the opportunity:
This is a fully remote role with flexible working, designed to support a healthy work‑life balance. You'll collaborate with a small, highly skilled team and meet in person for a team event at least quarterly (all expenses covered).
In this role, you will:
Deliver quality and regulatory client projects focused on medical devices with software elements
Educate clients on why regulatory documentation is needed, not just what is required
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, guiding discussions with clarity and confidence
Liaise closely with software engineers, product teams, HR, and senior stakeholders
Work collaboratively with colleagues to deliver joined‑up, practical solutions
Manage and deliver multiple client projects simultaneously in a consulting environmentEssential experience:
Background in software‑based medical devices
Experience working within medical device quality management environments
Experience working closely with engineers, supporting, guiding, and helping shape documentation at the shoulder of development teams
Strong understanding of quality and regulatory expectations for medical devices
Confident communicator, able to engage with stakeholders from highly technical engineers to senior leadership
Highly organised, methodical, and detail‑driven
Comfortable working independently while contributing to a collaborative teamDesirable experience:
Medical device technical documentation
ISO 13485 or other medical device standards
Gap analysis or internal auditing
Review of complex technical documentation
Process and procedure development
Exposure to AI or advanced software within medical devices
Client‑facing consultancy experienceWhy you will love working here:
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 (expenses covered)
Vitality Healthcare
Life Assurance (4x salary)
Training & Development: Ongoing professional development and support for further certifications
A values‑driven consultancy where quality, integrity, and collaboration are genuinely lived, not just written on a website
Progression opportunities as the medical device and international standards offering continue to grow
Salary description
£45000.00 - £55000.00 per year