Head of Regulatory Consulting & Operations

Standout; United Kingdom; Hybrid; GBP 81,000 - 99,000; Full time

Benefits offered by this job

Bonus

Car allowance

Pension

Flexible benefits

Job summary

Medical Device & IVD Consultancy in the UK seeks a Head of Regulatory Consulting & Operations to lead the regulatory consulting function. You will mentor a senior team, own client relationships, scope new projects, and craft practical regulatory strategies for CE/UKCA MDR/IVDR across the UK, EU, and US.

You will shape processes, ensure high-quality deliverables, and represent the firm at conferences and events, driving growth while maintaining a hands-on leadership style.

Qualifications

• 10+ years in medical device and/or IVD regulatory affairs.
• Experience compiling/reviewing CE and UKCA dossiers under MDR/IVDR and UK MDR.
• Knowledge of ISO 13485 and FDA QMSR (21 CFR Part 820).
• Proven leadership in consultancy or multi-client environments.
• Commercially minded with ability to scope and quote.
• US regulatory experience is a plus.
• Regulatory depth across devices/IVDs.
• Strong client-facing communication and attention to detail.

Responsibilities

• Lead and mentor the senior consulting team and maintain quality across outputs.
• Own client relationships as the main point of contact.
• Scope new projects, prepare quotes, and develop regulatory strategies.
• Review client deliverables including technical docs, QMS, and regulatory submissions.
• Lead next-step and feedback calls and manage feedback/complaints.
• Improve internal processes and governance.
• Represent the business at events and identify opportunities.

Skills

Leadership

Client management

Regulatory strategy

Project scoping

Regulatory submissions

QMS knowledge

MDR/IVDR

ISO 13485

Regulatory affairs

Travel flexibility

Education

Science/Engineering/Clinical degree

Job description

Head of Regulatory Consulting & Operations

Company: Medical Device & IVD Consultancy

Location: UK (Remote / Hybrid)

Salary: £90k+ (Bonus, Car Allowance, Pension and other benefits negotiable)

The Role in 20 Seconds

You’ve spent your career in medical device and IVD regulatory affairs, and at some point you realised you enjoy the client side as much as the technical side. You know MDR, IVDR and UK MDR inside out, you’ve compiled and reviewed more technical files than you can count, and you can scope, price and lead a project as confidently as you can critique a clinical evaluation.

You're probably a Regulatory Consultant now, or you've held titles like Head of Regulatory, Principal Consultant or RA/QA Manager. You don’t need a rigid job description to know what needs doing. You’re the person who spots it and gets it done.

If that’s you, and the idea of leading the consulting function of a growing consultancy excites rather than unsettles you, keep reading. This is an opportunity to develop a team, develop a business and develop personally...

The Company

A well-established, growing UK regulatory and quality consultancy supporting medical device and IVD manufacturers across the UK, EU and US. Its clients range from early-stage innovators to established manufacturers, across devices, IVDs, digital health and SaMD. The team is small, 10-20 people, settled and highly capable. The business has a clear growth plan, and this role sits at the heart of it.

What You’ll Actually Do

The core of it:

• Lead and mentor the senior consulting team, briefing them on clients and projects and holding the quality bar on everything that goes out
• Own client relationships and be their main point of contact - not just the escalation route
• Scope new projects, prepare quotes and build regulatory strategies that clients can actually act on
• Review client deliverables, including technical documentation, QMS and regulatory submissions, across the UK, EU and US
• Lead next-step and feedback calls, and own the feedback and complaints process
• Create and improve the internal processes the business runs on
• Represent the business at exhibitions, conferences and networking events, and spot the opportunities that come out of them

The less obvious bits that matter just as much:

• Setting the direction for how the consulting team works, with the autonomy to make decisions and the accountability that comes with them
• Bringing structure and forward planning to a fast-moving consultancy - meetings, events and client deadlines handled in good time rather than in a last-minute rush
• Knowing when a client needs the full regulatory answer and when they need a pragmatic, proportionate one - and having the credibility to make that call

Who We’re Looking For

You’ll be a natural fit if:

• You have 10+ years in medical device and/or IVD regulatory affairs, with a scientific, engineering or clinical background
• You’ve personally compiled and reviewed technical documentation for CE and UKCA marking under MDR/IVDR and UK MDR - this is essential
• You understand ISO 13485 and FDA QMSR (21 CFR Part 820) well enough to build a QMS from scratch or fix one that isn’t working
• You’ve led people, ideally in a consultancy or multi-client environment where priorities shift weekly
• You’re commercially minded - comfortable scoping, quoting and having the "what this will actually cost" conversation with a client
• US regulatory experience is a real plus
• Demonstrable regulatory depth across medical devices and/or IVDs
• Client-facing confidence and strong interpersonal and communication skills
• Excellent attention to detail, and the judgement to know what matters most
• A hands-on, get-stuck-in attitude - in a business this size, everyone pitches in
• Willingness to travel within the UK and occasionally internationally for clients and events

What’s Actually In It For You

• A senior leadership role on the leadership team, with real ownership of how the consulting function performs and grows
• A varied client base, so no two months look the same
• A settled, supportive team who are good at what they do
• Bonus, a car or cash allowance, and flexible working, including early Friday finishes
• The chance to shape how the consultancy runs, not just inherit it

The Honest Bit

This is a small consultancy, and that means the role is broad.

If you like being the person who connects the client, the team and the delivery, and you can switch between leading, reviewing and selling in the same afternoon, you’ll find this energising.

A note for independent consultants: if you’ve been working independently and love the consulting itself but miss being part of a team, this could be a great next step. You’d keep doing the work you enjoy, with the backing of a bigger team, colleagues to share the load and a wider spread of projects. You’d still have the atmosphere of a small company and real impact on where the business goes.

All applications are treated in the strictest confidence.