At Stirling Q&R, our medical device Q&R recruitment is carried out by consultants with genuine, hands-on knowledge of the quality and regulatory landscape. We specialize in placing quality assurance and regulatory affairs professionals across medical device manufacturers, Software as a Medical Device (SaMD) companies, digital health businesses, AI-enabled medical device developers, IVD manufacturers, and combination product environments. Whether you need permanent hires, contract support, or executive search, we find the specialists that move your business forward.
Our consultants understand the technical depth required in medical device and SaMD quality and regulatory roles. We go well beyond surface-level screening. When we assess a candidate, we explore whether their experience sits in Class I, Class IIa/IIb, or Class III devices, whether they have worked under EU MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, or MHRA frameworks, and whether they understand how IEC 62304 software lifecycle controls, ISO 13485 quality management systems, and ISO 14971 risk management principles interact in a regulated software medical device environment.
For SaMD and digital health hires, we go further. We explore intended purpose, software classification, verification and validation methodologies, usability engineering, design history documentation, post-market surveillance obligations, cybersecurity documentation, and regulatory submission experience across the UK, EU, and US. We understand the difference between a regulatory affairs professional who has touched software products and one who has truly owned SaMD regulatory strategy end to end.
That level of understanding means our shortlists are relevant, our placements stick, and our clients waste far less time interviewing candidates who look right on paper but fall short on sector depth.
Whether you are hiring a Regulatory Affairs Manager for a SaMD startup, a Quality Systems Lead for an EU MDR transition, a Post-Market Surveillance specialist, or a full QARA function for a scaling digital health company, Stirling Q&R builds your shortlist around technical substance, not keyword matching. We map the market, identify passive candidates, and qualify each one against your specific requirements before they reach you.
We work across the full spectrum of medical device and SaMD quality and regulatory hiring. Our deep network spans regulatory affairs professionals with FDA 510(k), De Novo, PMA, and CE marking experience, quality leads with ISO 13485 QMS implementation and audit exposure, software compliance specialists aligned to IEC 62304 and IEC 62366, and post-market surveillance leads managing MDR Article 83-86 obligations. We cover permanent, contract, and interim appointments, and we move fast without compromising on quality.
Share a job brief with us, whether it's a permanent regulatory affairs hire, a contract quality lead, a SaMD compliance specialist, or an executive search mandate and we'll come back to you with a tailored recruitment approach and an honest assessment of the talent market.
We provide a full suite of medical device and SaMD quality and regulatory recruitment services, covering contingent recruitment, retained executive search, contract and interim hiring, and built-to-spec team builds for scaling companies.
Roles we recruit for include:
• Regulatory Affairs Director, VP Regulatory Affairs, Head of Regulatory Affairs
• Regulatory Affairs Manager, Senior Regulatory Affairs Manager, Associate Director Regulatory Affairs
• SaMD Regulatory Affairs Specialist, Digital Health Regulatory Lead, Global Regulatory Strategist
• Quality Director, VP Quality, Head of Quality Assurance
• Quality Manager, Senior Quality Manager, QARA Manager, QARA Lead
• Quality Systems Manager, ISO 13485 QMS Lead, Quality Assurance Specialist
• Software Quality Assurance Manager, Design Assurance Engineer, IEC 62304 Compliance Lead
• Post-Market Surveillance Manager, PMS Specialist, Vigilance Manager, MDR Compliance Lead
• Clinical Evaluation Manager, Clinical Affairs Lead, CER/PMCF Specialist
• Risk Management Specialist (ISO 14971), Usability Engineering Lead (IEC 62366)
• Regulatory Affairs Associate, Regulatory Affairs Coordinator, Submissions Specialist
• Qualified Person for Pharmacovigilance (QPPV), Responsible Person (RP)
• Regulatory Consultant, Interim QARA Contractor, Fractional Head of Regulatory Affairs
• Cybersecurity and Product Security Specialist (medical device software)
• IVDR Regulatory Affairs Specialist, IVD Regulatory Consultant
Whether your product sits under EU MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, UK MDR 2002, or MHRA guidance, and whether your team is building a quality management system from scratch or navigating a complex global regulatory strategy, we will find the right people.
Making the wrong hire in medical device quality and regulatory affairs is expensive. A candidate who looks right on paper but lacks the depth you need in SaMD regulatory strategy, EU MDR compliance, software lifecycle controls, or post-market surveillance can cost you far more than the time it takes to find the right person. Stirling Q&R has built its reputation on getting these hires right first time. Our candidates are technically assessed, not just keyword matched. They stay, they perform, and they add real value to your quality and regulatory function. Talk to us about your next medical device, SaMD, digital health, or IVD Q&R hire.
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Learn more about the quality and regulatory recruitment services we provide to biotech companies. Or find your next biotech Q&R role.
