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 elementsEducate clients on why regulatory documentation is needed, not just what is requiredCreate, review, and structure medical device technical documentationSupport quality and design activities aligned to medical device regulations and standardsHelp clients compile and organise documentation into regulator‑ready formatsAdapt internal templates to meet specific client and product needsLead and contribute to client meetings, guiding discussions with clarity and confidenceLiaise closely with software engineers, product teams, HR, and senior stakeholders Work collaboratively with colleagues to deliver joined‑up, practical solutionsManage and deliver multiple client projects simultaneously in a consulting environmentEssential experience:Background in software‑based medical devicesExperience working within medical device quality management environmentsExperience working closely with engineers, supporting, guiding, and helping shape documentation at the shoulder of development teamsStrong understanding of quality and regulatory expectations for medical devicesConfident communicator, able to engage with stakeholders from highly technical engineers to senior leadershipHighly organised, methodical, and detail‑drivenComfortable working independently while contributing to a collaborative teamDesirable experience:Medical device technical documentationISO 13485 or other medical device standardsGap analysis or internal auditingReview of complex technical documentationProcess and procedure developmentExposure to AI or advanced software within medical devicesClient‑facing consultancy experienceWhy you will love working here:Salary between £45,000 and £55,000, depending on experience28 days annual leave, including bank holidays plus your birthday offFully remote working with quarterly in‑person team events (expenses covered)Vitality HealthcareLife Assurance (4x salary)Training & Development: Ongoing professional development and support for further certificationsA values‑driven consultancy where quality, integrity, and collaboration are genuinely lived, not just written on a websiteProgression opportunities as the medical device and international standards offering continue to grow
4 days ago