Senior Regulatory Affairs & Quality Manager - Cambridge, Cambridgeshire

£70,000–£85,000 DOE plus benefits

Have you taken a medical device through the FDA, and want to do it again where your work shapes the whole company? Our client is an innovative, founder-led medtech business developing cardiac health technology. Its UK quality and regulatory foundations are in place. Now it's expanding into the US, alongside the UK and EU, with the Middle East to follow.

They're looking for a senior regulatory professional who will set the strategy, and you'll also roll up your sleeves and write the submissions yourself.  This is a full time permanent hybrid roles, with 2 days a week in the office.

What you'll do

• Lead regulatory strategy for the US (FDA), UK and EU, and prepare the ground for new markets including the Middle East.
• Write and submit regulatory applications yourself, including FDA 510(k) and De Novo, UKCA and EU MDR technical documentation.
• Help take the company's devices from Class I self-certification to Class II and III.
• Interpret FDA and EU MDR guidance and turn it into clear, practical direction for the team, using AI tools to work smarter.
• Drive the Quality Management System to ISO 13485 and FDA QMSR and contribute to quality documentation directly.
• Oversee clinical governance and risk management (ISO 14971).
• Lead Notified Body audits, including BSI, and own those relationships.
• Decide when to bring in specialist consultants, then manage their scope and fees.
• Line-manage the UK Quality and Regulatory Manager.

What you'll bring

• A degree in life sciences, biomedical or clinical engineering, pharmacy, or a related field.
• A recognised regulatory affairs qualification, such as RAC (RAPS), TOPRA or a postgraduate RA qualification.
• 12+ years in medical device regulatory affairs and quality, with regulatory work as your main focus in recent years.
• First-hand FDA experience: you've written and submitted 510(k)s and handled FDA questions yourself.
• A strong understanding of FDA and CE / EU MDR processes, and where they differ.
• Experience driving a QMS to ISO 13485 and handling BSI or other Notified Body audits.
• A sharp eye for interpreting regulations, and the ability to explain what they mean in plain English.
• A hands-on approach: you're as happy writing the documents as signing them off.

It would be an advantage to have

• A cardiology or cardiac device background.
• Experience moving devices from Class I to Class II or III.
• Middle East registrations, such as Saudi SFDA or UAE.
• Start-up, scale-up or spin-out experience.
• Using AI tools in your day-to-day regulatory work.

What's in it for you.

• Hybrid working: 2 days a week in the Cambridge office.
• Real influence: you'll shape regulatory strategy as the company enters new markets.
• A team of your own, plus the backing of a founder-led, clinically driven business.
• The chance to bring cardiac technology to patients in the US and beyond.