Regulatory Specialist INTERN

About the Role

PONS Inc. develops physics-guided ultrasound image enhancement software with AI-optimized parameters. The software is regulated as Software as a Medical Device (SaMD).

Fellowship Duties and Responsibilities

• Build the electronic Quality Management System (eQMS)
• Design and stand up the eQMS from the ground up, aligned to ISO 13485:2016 and the FDA Quality Management System Regulation (21 CFR Part 820).
• Establish core quality processes: document and record control, design controls, training records, CAPA, and complaint handling.
• Structure the system to be auditable and inspection-ready.
• Develop the risk management framework and risk matrix
• Build the product risk management file and risk matrix under ISO 14971:2019 for the ultrasound image-enhancement software.
• Lead hazard identification, risk estimation, risk control, and benefit-risk analysis, linking the risk file to design and verification activities.
• Establish the software development lifecycle and design controls
• Stand up the software development system under IEC 62304, including software safety classification, planning, and configuration management.
• Define V&V planning and maintain the Design History File (DHF).
• Support the FDA 510(k) and related submissions
• Contribute to the Traditional 510(k) for PONS-IES (Class II, product code LLZ, 21 CFR 892.2050): predicate analysis, performance-testing documentation, labeling, and responses to FDA feedback.
• Prepare cybersecurity documentation under section 524B of the FD&C Act, including the software bill of materials (SBOM) and threat modeling.
• Lead human factors and usability engineering under IEC 62366-1 and FDA guidance, including URRA and task analysis.
• Support a Predetermined Change Control Plan (PCCP).
• Maintain the system and the regulatory picture over time
• Build the post-market surveillance and quality-monitoring framework.
• Keep regulatory intelligence current: monitor evolving FDA guidance for SaMD and EU MDR requirements.
• Produce clear, submission-ready technical documentation.

Qualifications

• Education
• Master's student or recent graduate from a Regulatory Affairs MS program.
• Suitable engineering disciplines: Biomedical Engineering, Biomedical Informatics & Data Science, Radiology & Biomedical Imaging.
• Skills
• Working knowledge of medical device quality and regulatory frameworks: ISO 13485, ISO 14971, IEC 62304, and FDA 510(k) or SaMD guidance.
• Strong technical writing skills; ability to translate engineering work into structured, auditable, submission-ready documentation.
• Careful attention to detail and comfort working with traceability.
• Technical background connecting to PONS's product: medical imaging, signal or image processing, or software development.
• Ability to work independently and manage a build-from-scratch scope.

Preferred Qualifications

• Hands-on experience building or maintaining a QMS or eQMS, especially in a startup or small-company setting.
• Prior involvement in an FDA submission (510(k), De Novo, or Pre-Submission) or in CE technical documentation.
• Research background in ultrasound, medical imaging, applied physics, or signal and image processing.
• Familiarity with medical device cybersecurity, human factors engineering, or the regulatory considerations for AI/ML-enabled devices.
• Regulatory Affairs Certification (RAC) or graduate coursework in regulatory affairs or regulatory science.
• Experience with design-control or eQMS tooling.