Senior RA/QA Consultant (Perm)

Senior Consultant | Regulatory Affairs &​ Quality | Software as a Medical Device (SaMD) &​ AI

£90,000 + Bonus | Fully Remote (UK) | Work from Anywhere in the UK / EU

Indo Search is partnering exclusively with one of the UK's leading specialist consultancies in Software as a Medical Device (SaMD), AI enabled medical devices and digital health .

From AI diagnostics and digital therapeutics to connected medical devices and clinical software, you'll help pioneering organisations navigate complex regulatory and quality challenges as they bring life-changing technologies to patients across the UK, Europe, the US and beyond.

No two projects are the same.

One week you could be defining the global regulatory strategy for an AI-enabled medical device. The next, leading an FDA submission, implementing a Quality Management System for an innovative startup, or advising a scale-up preparing for international expansion.

Working alongside an exceptional multidisciplinary team spanning Regulatory Affairs, Quality Assurance, Clinical Evaluation, Health Economics and Intellectual Property, you'll help shape both your clients' success and the future of one of the UK's most respected digital health consultancies.

What makes this stand out?

• Work exclusively with innovative Software as a Medical Device and AI technologies.
• Lead regulatory strategies and submissions across the UK, EU, US and international markets.
• Influence products from concept through to commercialisation.
• Collaborate with recognised experts across regulatory, quality, clinical and market access.
• Fully remote working with genuine flexibility around your lifestyle.
• Quarterly team meet ups to collaborate, learn and celebrate success.
• Competitive salary up to

£90,000 plus a structured bonus scheme.

• Play a key role in mentoring colleagues and shaping the continued growth of the consultancy.

We're looking for someone who has

• A proven track record supporting Software as a Medical Device (SaMD) and/or AI enabled medical devices (AIaMD) .
• Hands-on experience preparing Technical Documentation, Quality Management Systems and regulatory submissions for both

CE Marking and FDA .

• Strong working knowledge of ISO 13485 , ISO 14971 , IEC 62304 , IEC 82304-1 and IEC 62366-1 .
• Experience supporting multiple products across different stages of development.
• Excellent communication skills and the ability to build trusted relationships with clients and multidisciplinary teams.

If you're an experienced Regulatory or Quality professional looking to accelerate your career while helping shape the future of AI powered healthcare, this is an opportunity to make a genuine impact across some of the most exciting digital health technologies in development today.

Apply today or contact Indo Search for a confidential conversation.