Head of Regulatory Affairs & Compliance

Infermedica is hiring a Head of Regulatory Compliance to lead and personally run regulatory affairs for our AI-powered medical device software across Europe, the UK, and our growth markets. You will report to the CEO or the General Counsel, act as our primary liaison with notified bodies and regulators, and coordinate compliance across four domains: clinical, product, legal, and the customer implementation pipeline.

This is a leadership plus expert role. You will set the strategic regulatory direction, run the regulatory function day-to-day, and stay hands-on with technical documentation, submissions, and audits. The role combines ownership at the leadership-team level with real work on the files themselves.

Our regulatory footprint now spans multiple markets, modalities, and customer types. Infermedica's Medical Guidance Platform is certified as an EU Class IIb medical device under MDR, runs under an ISO 13485 quality management system, and is deployed by 100+ organisations in 30+ countries, including Australia's national triage service. Every new market, every LLM-based product capability, and every enterprise customer brings new regulatory questions, and we want a single senior owner who brings those threads together across clinical, product, legal, and delivery.

The Head of Regulatory Compliance is that owner. The role turns regulatory compliance from a reactive support function into a coordinated capability that unblocks sales, protects certification, and shapes how we build AI-driven software as a medical device.

What makes this role distinctive compared with a typical medtech regulatory job:

• The product is AI-driven SaMD, including conversational and LLM-based modalities, so the work sits at the frontier of MDR, the EU AI Act, and evolving guidance on adaptive algorithms.

• The customer base is international healthcare systems, insurers, and providers, so compliance is a commercial enabler: tenders, security and clinical safety questionnaires, and implementation sign-offs depend on it.

• The team is small and senior, so the person in this seat both sets direction and does the work.

Wherever you’re based in Europe, we’d love to hear from you. We’ll walk you through compensation and the benefits available in your location during our first conversation.

The role has three pillars. Expect to spend roughly a third of your time on each, shifting with audit cycles and market launches.

Strategic direction

• Own the regulatory strategy and roadmap: which markets we enter, in what order, under which classification and conformity route, and what evidence each requires.

• Advise the CEO, General Counsel, and leadership team on regulatory risk, timing, and cost of product and commercial decisions.

• Anticipate change (MDR amendments, EU AI Act obligations for high-risk AI, UK MDR reform, guidance on LLM-based and adaptive SaMD) and turn it into a plan before it becomes a blocker.

• Represent regulatory in product roadmap planning so that new capabilities are designed within an intended-use and classification strategy, not retrofitted to one.

Operational management

• Run the regulatory compliance function: priorities, cadence, tooling, budget, and external consultants and notified-body relationships.

• Lead and grow the regulatory team and set the standard for documentation quality.

• Coordinate compliance across the four domains (clinical, product, legal and customer-related processes), with clear owners, timelines, and a single view of open regulatory items.

• Maintain audit readiness at all times: ISO 13485 surveillance and recertification audits, notified-body technical documentation reviews, customer audits, and post-market surveillance reporting.

• Partner with Security and Engineering on medical-device cybersecurity, ensuring security risks, controls and evidence satisfy applicable regulatory and QMS requirements. Collaborate with the Security owner on ISO 27001, SOC 2 and related assurance activities where they intersect with regulated products.

• Provide regulatory guidance throughout product design and development, ensuring compliance requirements are addressed early, and own regulatory review.

Hands-on involvement

• Co-author and review technical documentation yourself: clinical evaluation, risk management , software lifecycle documentation , usability files, and post-market surveillance plans including  PMCF.

• Prepare and lead registrations and submissions in new markets, and manage correspondence with regulators through to decision.

• With help from your team, draft and maintain SOPs, policies, and the regulatory sections of customer-facing material (tender responses, security and clinical safety questionnaires, DPIAs where regulatory input is needed).

• Be the escalation point for hard questions from engineering, clinical, and sales, and answer them with references, not opinions.

The baseline is everything we expect of a senior regulatory specialist, proven rather than familiar, plus the UK clinical safety framework. On top of that we want evidence that you have successfully led regulatory work and people, ideally in cross-domain setups.

Must-have

• 8+ years in medical device regulatory affairs or quality and regulatory, with at least 3 years on software as a medical device, ideally AI-driven.

• Medical, scientific, engineering, or legal degree.

• Deep, working knowledge of EU MDR 2017/745 for software, including classification under Rule 11, clinical evaluation of SaMD, and significant-change assessment.

• Experience operating inside an ISO 13485:2016 certified QMS, and authoring technical documentation and procedures that passed notified-body assessment.

• Hands-on command of the SaMD standards stack: ISO 14971, IEC 62304, IEC 62366-1, and the post-market surveillance and vigilance requirements that go with them.

• Proven ability to own the SaMD risk management process and manage clinical risk across the entire product lifecycle, from design and release through post-market surveillance and change control, including clinical risk management under the NHS standards DCB0129/DCB0160. Experience as, or working closely with, a Clinical Safety Officer is a strong plus.

• Direct experience as the named contact with a notified body or regulator, including audits and formal correspondence.

• Demonstrated experience as the accountable regulatory lead for at least one successful market authorisation in a major non-EU jurisdiction: the US (e.g. 510(k), De Novo), Canada (MDL), Australia (ARTG inclusion), Japan (PMDA) or Brazil (ANVISA notificação/registro).

• Track record of leading people or a function: setting priorities, managing consultants, and developing at least one direct report.

• Fluent written and spoken English; able to write regulator-grade documents without editing support and to lead meetings and substantive technical discussions with regulators, notified bodies, auditors and other external stakeholders.

Strong advantages

• Australia: TGA ARTG inclusion for SaMD, including classification and evidence expectations for clinical decision support software.

• Canada: Health Canada Medical Device Licence for software, and MDSAP.

• United States: FDA SaMD pathways (510(k), De Novo), Clinical Decision Support guidance, and Predetermined Change Control Plans for AI-enabled devices.

• Brazil: ANVISA registration for software medical devices.

• EU AI Act readiness work for high-risk AI systems.

• Certified ISO 13485 lead auditor, or RAC (Devices) or equivalent credential.

• Experience with LLM-based or adaptive algorithms in a regulated product.

• ISO 27001 or SOC 2 audit experience, or other work at the intersection of information security assurance and regulated software.

How you work

• Comfortable switching in one day between a board-level risk discussion and a line-by-line review of a risk management file.

• Excellent communicator comfortable with setting the direction and leading complex projects.

• Explains regulatory constraints to engineers, clinicians, and salespeople in their language, and proposes options rather than only objections.

• Organised and calm under audit; builds systems that make the next audit easier than the last.

• Works well remotely across time zones, and travels when it matters.