Senior Regulatory Affairs & Quality Manager - Cambridge, Cambridgeshire

£65,000–£80,000 DOE plus benefits

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.

They're looking for a senior regulatory professional who will set and implement the strategy 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.
• Write and submit regulatory applications yourself, including FDA 510(k) and De Novo, UKCA and EU MDR technical documentation.
• 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.
• 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.