Quality & Regulatory Specialist

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 environment

Essential 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 team

Desirable 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 experience

Why 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