Strategic Regulatory Lead for AI‑Driven SaMD

Infermedica; Polska; Hybrid; PLN 655,000 - 917,000; Full time

Job summary

Infermedica is seeking a Head of Regulatory Compliance to lead regulatory affairs for our AI-powered medical device software across Europe, the UK, and growth markets. You will own strategy, run the function, and stay hands-on with technical documentation, submissions, and audits.

The role combines leadership with practical work, coordinating clinical, product, legal, and delivery processes to unblock sales and protect certification in a fast-evolving regulatory landscape.

Qualifications

• Senior regulatory experience in medical devices, including software as a medical device (SaMD).
• Proven ability to lead regulatory programs and teams across multiple markets.
• Fluent written and spoken English; capable of regulator-grade documentation.

Responsibilities

• Own regulatory strategy and roadmap across markets and product classifications.
• Coordinate compliance across clinical, product, legal and delivery domains with clear owners.
• Lead and grow the regulatory function, manage audits, and oversee submissions.
• Draft and review technical documentation and SOPs; ensure audit readiness.
• Prepare registrations and submissions in new markets; manage regulator correspondence.
• Provide guidance on regulatory constraints to engineering, clinical and sales teams.

Skills

Regulatory leadership

Regulatory strategy

Cross-domain coordination

Regulatory documentation

Audits & liaison

Executive communication

Education

Degree in medicine, science, engineering or law

Tools

ISO 13485

MDR 2017/745

SaMD standards (ISO 14971, IEC 62304, IEC 62366-1)

Job description

Infermedica is seeking a Head of Regulatory Compliance to lead regulatory affairs for our AI-powered medical device software across Europe, the UK, and growth markets. You will own strategy, run the function, and stay hands-on with technical documentation, submissions, and audits.

The role combines leadership with practical work, coordinating clinical, product, legal, and delivery processes to unblock sales and protect certification in a fast-evolving regulatory landscape.