Quality & Regulatory Specialist

Are you passionate about quality, regulation, and building safe medical technologies? Ready to take the next step in your career within a growing consultancy where your expertise, curiosity, and impact genuinely matter?

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