Remote Regulated SaMD Product Manager (MDR/EU)

Stealth Healthcare AI Startup; Italia; On-site; EUR 50,000 - 65,000; Full time

Benefits offered by this job

Best-in-class equipment

Job summary

Stealth Healthcare AI Startup is seeking a Product Manager to bridge product development with regulatory realities under EU MDR. You will translate complex requirements into actionable product decisions and roadmaps, coordinating with Clinical, Engineering, and Quality teams to embed regulatory readiness from day one.

You will own the regulatory-informed product roadmap, define intended use and claims, and drive traceability, risk management, and usability throughout the lifecycle, partnering

Qualifications

• Experience taking a medical device or SaMD through MDR authorisation.
• Solid understanding of MDR and related standards (ISO 13485, IEC 62304, IEC 14971).
• Ability to translate regulatory requirements into product decisions and roadmaps.
• Experience bridging product, clinical, and regulatory teams in regulated environments.

Responsibilities

• Own the product roadmap for features with clinical or regulatory relevance.
• Translate regulatory requirements into concrete product and engineering specs.
• Define intended purpose, claims, and user workflows for regulatory classification.
• Ensure traceability, risk management, and usability in the product lifecycle.
• Collaborate with Quality/Regulatory on documentation and post-market inputs.
• Prioritise features across MVP, Class I, and higher classifications.

Skills

MDR knowledge

Regulatory strategy

Product management

Cross-functional collaboration

Education

Biomedical Engineering degree

Tools

ISO 13485

IEC 62304

IEC 14971

IEC 62366-1

Job description

Stealth Healthcare AI Startup is seeking a Product Manager to bridge product development with regulatory realities under EU MDR. You will translate complex requirements into actionable product decisions and roadmaps, coordinating with Clinical, Engineering, and Quality teams to embed regulatory readiness from day one.

You will own the regulatory-informed product roadmap, define intended use and claims, and drive traceability, risk management, and usability throughout the lifecycle, partnering