Head of Regulatory Compliance for AI‑Driven SaMD

Infermedica; Województwo mazowieckie; Remote; PLN 350,000 - 600,000; Full time

Job summary

Infermedica is seeking a Head of Regulatory Compliance to lead regulatory affairs for our AI‑driven medical device software across Europe, the UK, and growth markets. You will oversee submissions, audits, and four domains: clinical, product, legal, and customer implementation, reporting to CEO or GC.

You will drive strategic direction, stay hands‑on with technical documentation, and coordinate with notified bodies to protect certification while enabling growth.

Qualifications

• 8+ years in medical device regulatory affairs or quality and regulatory
• Experience with software as a medical device (SaMD)
• Hands‑on with regulatory documentation and audits
• Proven leadership of regulatory work and people

Responsibilities

• Set regulatory direction and run the function day‑to‑day
• Lead regulatory strategy and roadmap across markets
• Advise leadership on regulatory risk, timing, cost, and product decisions
• Manage registrations and submissions in new markets
• Maintain audit readiness for ISO 13485 and regulator reviews
• Collaborate on cybersecurity and safety with Security and Engineering
• Draft and review regulatory documentation and SOPs
• Serve as primary liaison with regulators and notified bodies

Skills

Regulatory leadership

Medical device regulatory

Cross‑border compliance

Audits & inspections

Regulatory strategy

Education

Medical, scientific, engineering, or legal degree

Tools

ISO 13485

ISO 14971

IEC 62304

IEC 62366-1

Job description

Infermedica is seeking a Head of Regulatory Compliance to lead regulatory affairs for our AI‑driven medical device software across Europe, the UK, and growth markets. You will oversee submissions, audits, and four domains: clinical, product, legal, and customer implementation, reporting to CEO or GC.

You will drive strategic direction, stay hands‑on with technical documentation, and coordinate with notified bodies to protect certification while enabling growth.