AI SaMD Quality & Regulatory Lead (Hybrid)

Heim; Greater London; Hybrid; GBP 60,000 - 80,000; Full time

Benefits offered by this job

Equity options

33 days holiday (plus birthday)

Hybrid work from Shoreditch

Direct ownership of QA/regulatory

Job summary

Heim is hiring its first Quality & Regulatory Affairs Manager to own how our software products are built safely and compliantly. You will lead the QMS, regulatory submissions, and information governance to enable rapid, trusted deployments.

You’ll work with our founders and clinical leadership to scale MDR readiness, UKCA registrations, and post-market activities while fostering a startup-friendly, AI-enabled compliance culture.

Qualifications

• SaMD experience in regulatory affairs for software as a medical device.
• Experience running a full ISO 13485 quality management system end to end.
• Experience designing or running post-market surveillance and validation studies.
• Solid knowledge of UK GDPR, DPIAs, ISO 27001, and comfortable acting as DPO.

Responsibilities

• Define regulatory strategy for MDR filings and product classifications.
• Own ISO 13485 QMS and risk management (ISO 14971).
• Oversee software lifecycle and usability standards (IEC 62304/IEC 62366).
• Develop technical documentation for Class I and II devices, including CEP/CER, risk files, and software life cycle docs.
• Lead UKCA registration for Class II and post-market surveillance.
• Set up AI feature change control to maintain regulatory position.
• Advise on regulatory routes for new markets (e.g., US).
• Act as Heim's Data Protection Officer and manage governance submissions (DTAC, DSPT).
• Maintain ISO 27001 certification and lead audits.

Skills

SaMD experience

QMS owner

Post-market proven

Governance fluent

Pragmatic

AI fluent

Calm and meticulous

Job description

Heim is hiring its first Quality & Regulatory Affairs Manager to own how our software products are built safely and compliantly. You will lead the QMS, regulatory submissions, and information governance to enable rapid, trusted deployments.

You’ll work with our founders and clinical leadership to scale MDR readiness, UKCA registrations, and post-market activities while fostering a startup-friendly, AI-enabled compliance culture.