Job Description
📋 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.
