AI Regulatory Engineer

Description

The AI Regulatory Engineer helps bring AI-enabled healthcare software to release and sets direction for engineering work on AI/ML product releases in healthcare. This person sits inside cross-functional teams with data scientists, software developers, data engineers, and quality, clinical, and product stakeholders.

Responsibilities

• Advise on regulatory matters from early concept through release and after the product is on the market.
• Turn the company's regulatory expectations into concrete requirements for AI, software, data, and model work.
• Help shape regulatory strategy, and take part in risk assessments, change assessments, and release readiness reviews.
• Review and write technical documents such as intended use, traceability, risk management, data governance, model performance, verification, and validation.
• Judge whether changes to software, models, training data, workflows, or intended use carry regulatory impact.
• Support submissions, audits, and regulatory questions, and keep product documentation current.
• Help teams work through model limitations, bias, robustness, explainability, monitoring, and version control.
• You are hands-on and practical, and you are comfortable joining technical discussions, team planning, risk reviews, and release activities.

Requirements

• Background in regulatory affairs for medical devices, SaMD, digital health, or healthcare software.
• Working knowledge of AI/ML development and the regulatory expectations that apply to it.
• Understanding of risk management, design controls, software lifecycle processes, and change control.
• Ability to work well with technical teams and explain things clearly.
• Experience in regulated product development.

Conditions

Relocation assistance is not provided.

This role is onsite.

Benefits

• Total rewards package meant to give you room to grow and flexibility in how you work.
• Pay and benefits in line with a large global employer, plus a culture focused on care, collaboration, and support.