Staff Regulatory Affairs Engineer

Responsibilities

• Lead the planning, authorship, and submission of regulatory filings (510(k), De Novo, Q-Submissions) for AI/ML-enabled software.
• Develop and execute regulatory strategies for new product introductions and major software updates.
• Participate in Design Reviews and Change Control Boards to assess regulatory impact of software changes, evaluating AI models and retraining pipelines.
• Support maintenance of Quality Management System (QMS) ensuring compliance with 21 CFR 820 and ISO 13485.
• Review and approve labeling, marketing materials, and user manuals.
• Monitor post-market performance of AI models and lead assessments for regulatory reporting (eMDRs).
• Educate cross-functional teams on regulatory principles.

Basic Qualifications

• Education: Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or related field.
• Experience: 7+ years in Regulatory Affairs in medical device industry, with 3+ years in SaMD or Digital Health.
• Proven track record of authoring and clearing US FDA Class II submissions (510(k) or De Novo).
• Experience interfacing with FDA reviewers.
• Technical fluency in software architecture, cloud infrastructure, AI/ML concepts; familiarity with IEC 62304 and FDA Software Validation Guidance.

Preferred Qualifications

• Direct experience with regulatory submissions involving Machine Learning, Deep Learning, or Computer Vision.
• Familiarity with Good Machine Learning Practice (GMLP) and Predetermined Change Control Plans (PCCP).
• Experience with international registrations (EU MDR, Health Canada).
• Ability to review statistical analysis plans and clinical validation reports.
• Experience in Agile/Scrum environments.