Staff Regulatory Affairs Engineer

📋 Description

• Lead planning, authorship, and submission of AI/ML SaMD filings (510(k), De Novo).
• Partner with Product/Clinical/Engineering to interpret FDA AI/ML and PCCP.
• Own internal QMS support and regulatory compliance during audits (FDA/ISO).
• Manage regulatory impact of software changes via Design Reviews and Change Control Boards.
• Review labeling and marketing materials for compliant claims.
• Lead post-market surveillance, regulatory reporting (eMDRs), and recalls.

🎯 Requirements

• Education: Bachelor's in Biomedical/Software Regulatory Science or related.
• Experience: 4-6+ years in Regulatory Affairs; 3+ years SaMD/Digital Health.
• Submission Expertise: Clear US FDA Class II submissions; interface with FDA reviewers.
• Technical Fluency: Software architecture, cloud, AI/ML; IEC 62304; Software Validation.
• AI/ML Specifics: ML/DL/Computer Vision submissions; GMLP; PCCP.
• International Experience: EU MDR CE Marking for software; Health Canada.

🎁 Benefits

• Inclusive medical, dental, and vision coverage; family benefits and travel reimbursements.
• 401k with 2% company match (traditional or Roth).
• Learning and development stipend.
• Inclusive culture with accommodations for disabilities.