Principal Regulatory Affairs Specialist

What you'll do

• Lead cross-functional regulatory planning and global submissions, including FDA filings and EU MDR CE Marking.
• Advise on AI/ML-enabled device strategies, software changes, and pre-market and post-market regulatory compliance.
• Engage with regulatory agencies, track digital health policy, and mentor internal teams on regulatory requirements.

What they ask for

• Bachelor’s degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field.
• 10+ years of direct medical device Regulatory Affairs experience, including 4+ years focused on SaMD, SiMD, or complex digital health solutions with deep AI/ML knowledge; alternatives: 6+ years and a Master’s degree, or 4+ years with a PhD.
• Experience successfully clearing or approving SaMD applications (e.g., 510(k), De Novo, or CE Mark) with FDA and/or EU Notified Bodies.
• Knowledge of IEC 62304, ISO 14971, and IEC 82304-1.

Nice to have

• Direct experience submitting Predetermined Change Control Plans (PCCPs) for AI/ML algorithms.
• Knowledge of clinical trial strategy and clinical study design.

Pay

USD 188,000 - USD 240,000 base salary

Tools

SaMD, SiMD, AI/ML, IEC 62304, ISO 14971, IEC 82304-1, FDA, EU MDR

AI focus

Regulatory strategy and submissions for AI/ML-enabled medical devices, including Good Machine Learning Practice and Predetermined Change Control Plans.