Senior Regulatory Affairs Program Manager

What you'll do

• Plan, author, and submit FDA filings such as 510(k), De Novo, and Q-Submissions; communicate with FDA reviewers.
• Develop regulatory strategies for new products and software updates, assessing AI/ML changes and applicable submission pathways.
• Support QMS compliance, audits, promotional review, and post-market surveillance, including complaint reporting and field actions.

What they ask for

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical/scientific field.
• 4-6 + years of Regulatory Affairs experience in the medical device industry, including at least 3 years focused on SaMD or Digital Health.
• Track record authoring and clearing US FDA Class II submissions (510(k) or De Novo), including direct interaction with FDA reviewers.
• Ability to understand software architecture, cloud infrastructure, and AI/ML concepts; familiarity with IEC 62304 and FDA Guidance on Software Validation.

Nice to have

• Regulatory submissions involving Machine Learning, Deep Learning, or Computer Vision; familiarity with GMLP and PCCP.
• International registrations, including EU MDR (CE Marking) or Health Canada; statistical analysis and clinical validation; or Agile/Scrum experience.

Pay

$168K – $225K • Offers Equity

Tools

AI/ML, SaMD, 510(k), De Novo, Q-Submissions, 21 CFR 820, ISO 13485, IEC 62304

AI focus

Regulatory strategy and submissions for AI/ML medical device software, including validation and monitoring of adaptive algorithms, change-impact assessment for models and retraining pipelines, and post-market performance monitoring.