Medical Device Regulatory Specialist (SaMD Focus)

About the Role: Shaping the Future of Digital Health

We are a fast-growing digital health and AI startup developing next-generation software-as-a-medical-device (SaMD) solutions. Our AI-powered platform is designed to assist healthcare professionals with clinical decision support and predictive analytics. We are seeking a proactive Regulatory Specialist to lead our strategy for navigating the complex FDA and international regulatory landscape for AI in healthcare.

Key Responsibilities

You will be the owner of our regulatory pathway, responsible for bringing our innovative product to market and ensuring ongoing compliance.

• Develop and execute the regulatory strategy for our AI-based SaMD, identifying the appropriate FDA submission pathway (e.g., 510(k), De Novo) and requirements for international markets.
• Prepare, compile, and submit high-quality regulatory documentation, including Pre-Submissions, Technical Files, and Design History Files.
• Ensure our quality management system (QMS) and all product development activities comply with FDA 21 CFR Part 820, ISO [phone hidden], and IEC [phone hidden] standards.
• Stay current with evolving FDA guidelines for AI/ML-Based Software as a Medical Device and communicate their impact to the product and engineering teams.
• Manage post-market surveillance activities, including complaint handling, adverse event reporting, and supporting audits.

Qualifications and Experience

We are looking for a hands-on specialist who thrives in a startup environment and understands the unique challenges of regulating AI in medicine.

• Minimum 2-3 years of direct regulatory affairs experience in the medical device industry, with a strong preference for candidates with SaMD, digital health, or AI/ML experience.
• Proven track record of successful FDA submissions (510(k) or PMA) from preparation through to clearance/approval.
• In-depth knowledge of QMS requirements (ISO [phone hidden], 21 CFR 820) and software lifecycle standards (IEC [phone hidden]).
• Experience with clinical evaluations and understanding of real-world evidence (RWE) generation for regulatory purposes is a plus.
• Exceptional attention to detail, superb written communication skills, and the ability to translate complex technical information into regulatory arguments.

What We Offer

This is a unique opportunity to be a foundational member of our team, directly influencing a product that aims to improve patient outcomes. You will work closely with our founders and have a significant impact on our company's trajectory.