Staff Regulatory Affairs Engineer

Role Overview

• Submission Leadership (AI/ML SaMD): Lead the planning, authorship, and submission of regulatory filings (510(k), De Novo, Q-Submissions) for AI/ML-enabled software. You will be the primary author, not just a reviewer, translating complex technical and clinical data into compelling regulatory narratives.
• Regulatory Strategy & AI Policy: Develop and execute regulatory strategies for new product introductions and major software updates. You will serve as the internal authority on the FDA’s evolving AI/ML Action Plan, guiding the business on how to validate and monitor adaptive algorithms.
• Design Control & Change Impact: Participate in Design Reviews and Change Control Boards (CCB) to assess the regulatory impact of software changes. You will determine when a new 510(k) or 'Letter to File' is required, specifically evaluating changes to AI models and retraining pipelines.
• QMS & Internal Compliance: Support the maintenance of the Quality Management System (QMS) by ensuring regulatory requirements (21 CFR 820, ISO 13485) are reflected in internal procedures. You will act as the Regulatory representative during internal and external audits (FDA, ISO).
• Promotional Review: Review and approve labeling, marketing materials, and user manuals to ensure claims are substantiated and consistent with cleared indications for use.
• Post-Market Surveillance & Vigilance: Partner with Quality to monitor post-market performance of AI models. You will lead the assessment of complaints for regulatory reporting requirements (e.g., eMDRs) and manage any necessary recalls or field actions.
• Cross-Functional Coaching: Educate technical teams on regulatory principles, demystifying the submission process and helping engineers understand how their documentation directly supports regulatory clearance.

Requirements

• Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical/scientific field.
• Experience: 7+ years of experience in Regulatory Affairs within the medical device industry, with a minimum of 3 years focused on Software as a Medical Device (SaMD) or Digital Health.
• Submission Expertise: Proven track record of authoring and clearing US FDA Class II submissions (510(k) or De Novo). Experience interfacing directly with FDA reviewers during the review clock.
• Technical Fluency: Ability to understand software architecture, cloud infrastructure, and AI/ML concepts sufficiently to describe them to regulators. Familiarity with IEC 62304 and FDA Guidance on Software Validation.

Tech Stack

• Cloud

Benefits

• Inclusive healthcare and benefits: On top of comprehensive medical, dental, and vision coverage, we offer employees and their family members help with gender-affirming care, tools for family and fertility planning, and travel reimbursements if healthcare isn’t available where you live.
• Planning for the future: Start saving for the future with our traditional or Roth 401k retirement plan options which include a 2% company match.
• Modern life stipends: Manage your own learning and development