Senior Regulatory Consultant
Medical Devices | Birmingham (Hybrid) |
At Taylored Consultancy, we don't just talk about culture, we live it. One team. One culture. Everyone matters. If you're a medical device regulatory specialist looking for real ownership, genuine investment in your growth, and a team that celebrates every win together, we want to hear from you.
LIFE AT TAYLORED CONSULTANCY
Real investment in you — we continually create opportunities for you to self-develop, your growth is part of how we grow.
The best of both worlds — fantastic hybrid working, with a buzzing, vibrant office right in Birmingham city centre when you want the energy of the team around you.
One team, one culture — no silos, no politics - just people who genuinely have each other's backs and celebrate every win together.
You matter here — we cherish our staff. Every voice is heard, every contribution is recognised, always.
A package that respects you — A competitive salary coupled with a 35-hour working week to give you a better work-life balance.
THE ROLE
As a growing consultancy, we punch well above our weight and it's earned us excellent clients who trust us with real regulatory responsibility. This role exists because that trust is growing faster than our delivery capacity. We need a senior regulatory expert who can build on what we've already created: strengthening our anchor client relationships, supporting the wider Medical Devices team, and helping us take on the accounts that come next.
What You'll Be Doing
— Deliver end-to-end regulatory affairs support across IVD and medical device clients, Class I–III, including combination devices and companion diagnostics.
— Contribute to SaMD regulatory strategy and classification across UK, EU and US markets, including 510(k) submissions (PMA experience an advantage for higher-risk devices).
— Review and strengthen client QMS systems, applying process-improvement methods to close gaps efficiently.
— Develop and review product claims and plan claims substantiation strategies.
— Maintain regulatory intelligence across UK, EU and US markets relevant to the client portfolio.
— Advise on smart health tech and AI-enabled medical devices, including associated cybersecurity considerations.
— Liaise directly with Notified Bodies on behalf of clients.
— Mentor junior team members as the division grows.
WHAT YOU'LL BRING
These are the essentials - the non-negotiables we need to see in your background:
— Proven regulatory affairs experience across medical devices, spanning Class I–III.
— Working knowledge of SaMD regulatory pathways in the UK, EU and US (510(k)).
— Experience developing and reviewing product claims, and planning substantiation.
— QMS experience.
— Previous consultancy or client-facing regulatory role.
— Strong communication skills across technical and non-technical stakeholders; resilient and comfortable managing multiple concurrent client projects.
Nice-to-Haves That'll Make You Stand Out
Nobody ticks every box, and that's fine, this list helps us understand where your particular strengths lie:
— Combination device or companion diagnostic experience.
— Clinical experience
— Smart health tech and AI-in-medical-device knowledge.
— Cybersecurity awareness for connected or software-driven devices.
— Lead Auditor qualification (ISO 13485).
— Direct experience liaising with Notified Bodies.
The Person
— Driven and self-motivated, with the resilience to manage multiple competing client deadlines.
— Strong client-facing manner, able to build trust quickly with new contacts.
— Able to flex communication style across stakeholders, from technical specialists to board-level clients.
ABOUT TAYLORED CONSULTANCY
We're a regulatory compliance consultancy working across cosmetics, food supplements, and medical devices, with offices in Birmingham, Belfast, Dubai and Sydney and clients spanning the globe! But what really sets us apart is how we work together: as one team, one culture, where everyone matters and every win, however big or small - gets celebrated.
Ready to Join Us?
If this sounds like the team you've been looking for, we'd love to hear from you. Apply today and let's talk about what's next, for the role, and for you.
