Director of Regulatory Affairs
Company: Unity Talent Solutions Agency
- Location: United Kingdom
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
The Company
Join an established, commercially proven HealthTech company that brings hospital-level monitoring into the home. The connected wearable and software platform are used in hospital-at-home programmes, in post-discharge care and by Pharma sponsors in clinical trials.
The Role
You will be our most senior regulatory professional and the owner of regulatory strategy across hardware and software, in the EU, UK and US. This is a hands-on leadership role in a lean team: you will set the strategy, write and review the documents, and work side by side with engineering, product, quality and our pharma partners. You will find pragmatic routes to compliance that let a small company move quickly without cutting corners.
What you'll do
- Own regulatory strategy for our wearable, connected peripherals and software platform, including SaMD and AI/ML features.
- Lead our EU MDR transition from MDD, including technical documentation and notified body interactions.
- Plan, author and manage FDA submissions (510(k), and De Novo or Pre-Sub where needed) for next-generation hardware and new algorithms.
- Maintain UKCA/MHRA and CE compliance; contribute to MDSAP readiness alongside Quality.
- Assess the impact of emerging regulation, including the EU AI Act and medical device cybersecurity requirements, and turn it into practical plans.
- Review complaints, CAPAs and design changes for regulatory impact; own vigilance and MDR (adverse event) reporting decisions.
- Partner with engineering on IEC 62304, ISO 14971 and design controls so documentation is built in, not bolted on.
- Support pharma partners and sponsors: review RFPs and protocols, answer regulatory questions, and front regulatory topics in partner audits.
- Represent RA in ISO 13485 surveillance, notified body and customer audits.
- Coach the Quality team on regulatory matters, and build the RA function as it grows, including hiring and developing a future RA specialist.
What you'll bring
- 10+ years in medical device regulatory affairs, including leading submissions end to end.
- Direct experience with both hardware and software devices; IEC 62304 experience is essential.
- Fluency in both EU and US frameworks: you have taken products through EU MDR and 510(k), and understand the De Novo pathway.
- A track record in a smaller or growth-stage company that brought products to market, where you did the work yourself.
- Strong judgment: you interpret regulations flexibly and explain risk clearly to nonregulatory colleagues.
- Comfort working closely with engineers and influencing without heavy process.
Nice to have
- Wearables, remote patient monitoring or connected health experience.
- AI/ML device submissions or EU AI Act knowledge.
- Medical device cybersecurity (FDA premarket guidance, IEC 81001-5-1).
- Supporting pharma or clinical trial sponsors (e.g. devices used in decentralized trials).
- MDSAP or UKCA experience; RAPS (RAC) certification.
