Senior Regulatory Affairs Specialist

Regulatory Consultant (Permanent) – SaMD and AI Focus

Fully Remote UK or Ireland - Must be based in the UK / Ireland with the right to work

Imagine starting your day from the comfort of your home office, connecting with a MedTech startup on the cusp of launching their first AI-powered diagnostic platform. They’re bright, ambitious, and full of ideas, but need someone with your regulatory know-how to steer their path to market.

By lunchtime, you’re deep in a design review for another client, translating complex engineering data into compliant, audit-ready documentation. Your afternoon might be spent advising a founder on clinical evaluation strategy or reviewing a technical file for FDA submission.

Every day brings something different, but each moment builds towards the same goal - helping innovative MedTech companies get their products safely and successfully into global markets.

You’ll be part of a small but growing consultancy that specialises in supporting SaMD and digital health developers across the UK and EU. Their collaborative, knowledge-sharing culture means you’ll never work in isolation, and you’ll have the chance to grow your expertise alongside other talented professionals who share your passion for innovation.

The Opportunity

• Variety and Impact: Work on diverse, high-impact projects spanning early-stage startups to established SMEs developing cutting-edge SaMD and AI-driven devices.
• Flexibility: A fully remote position giving you the freedom to work from anywhere in the UK or Ireland.
• Growth and Leadership: An opportunity to grow and lead a developing division within a consultancy expanding its SaMD and digital health offering.
• Technical Depth: The chance to round off and fine-tune your specialist technical skills in SaMD while tackling complex regulatory challenges.
• Career Development: Join a consultancy with a proven record of internal development and promotion.
• Collaborative Environment: Work alongside experienced specialists who value honesty, integrity, and humour in their daily interactions.
• Purpose: Play a direct role in bringing meaningful health technologies to patients worldwide.

How You’ll Make an Impact

• Guide clients through regulatory pathways for EU MDR, IVDR, and FDA submissions.
• Prepare and review technical documentation, design dossiers, and clinical evaluation reports.
• Support design and product risk management activities from concept to post-market phases.
• Advise on post-market surveillance and vigilance processes.
• Help shape early-stage development strategies for new SaMD and AI-based technologies.
• Ensure compliance with global regulatory requirements and contribute to client success stories.

The Kind of Person Who Will Thrive Here

• Proven experience in regulatory affairs, ideally within SaMD, AI, or digital health.
• Strong understanding of EU MDR, IVDR, and FDA 510(k) frameworks.
• Background in engineering, life sciences, or a related technical discipline.
• Excellent communication skills and a personable, solutions-focused approach.
• The confidence to manage multiple projects while providing clear, practical regulatory advice.

Who You’ll Be Joining

This is a small but expanding regulatory consultancy that has built its reputation on trust, quality, and deep technical expertise. The team is growing to meet demand from MedTech innovators developing next-generation digital and software-based medical devices. Their collaborative culture encourages learning, career development, and a sense of shared purpose - helping clients overcome regulatory hurdles while enabling safe, effective technologies to reach patients faster.