Job Description

Position Overview: (Contract-to-Hire)

The FDA SaMD Regulatory Specialist will lead and coordinate the development, documentation, and submission of an FDA De Novo application for our AI-driven ultrasound product. This individual will be responsible for interfacing with multiple external consultants (e.g., regulatory, clinical, biostatistical, quality, cybersecurity), as well as internal developers, clinical affairs, and product management teams. They will ensure that all elements—device description, clinical study design, validation data, risk assessments, labeling, and cybersecurity—are aligned with FDA expectations and requirements. Beyond the immediate De Novo submission, this role will also be integral to planning and managing future related applications and regulatory strategies for ongoing product evolution and additional indications.

Key Responsibilities:

Regulatory Strategy & Execution:

• Develop and refine the regulatory strategy for the SaMD De Novo submission, ensuring compliance with all applicable FDA regulations, guidance documents, and recognized standards (e.g., ISO 14971, IEC 62304).
• Interpret FDA feedback and integrate recommendations into updated submission documents, including the device description, clinical protocol, labeling, and cybersecurity validation plans.
• Guide the preparation and submission of regulatory packages, ensuring completeness, accuracy, and timely delivery of all required sections (e.g., clinical study protocols, software documentation, test results, labeling).

Cross-Functional Coordination:

• Act as the primary regulatory liaison between internal product development teams and a network of external consultants (regulatory, clinical, biostatistical, and quality experts).
• Coordinate with clinical affairs and biostatisticians to ensure the clinical study design, endpoints, sample size, patient demographic representation, and analytical methods meet FDA expectations and De Novo requirements.
• Collaborate closely with software developers, data scientists, and cybersecurity specialists to ensure the SaMD’s technical documentation, algorithm description, data flow, quality criteria for image analysis, and cybersecurity measures are appropriately described and validated.

Documentation & Quality Management:

• Oversee the creation and maintenance of structured, audit-ready regulatory documentation, including design history files, technical documentation, risk management files, and clinical evaluation reports.
• Review labeling strategies and instructions for use, ensuring alignment with FDA’s recommendations for clarity, device output interpretation, and inclusion/exclusion criteria
• Ensure ongoing compliance with relevant QMS standards (e.g., ISO 13485) and FDA Quality System Regulation (QSR), as well as adherence to good clinical practices (GCP).

Stakeholder Communication & Representation:

• Prepare and present regulatory updates, timelines, and status reports to senior management, ensuring stakeholders are informed of potential risks, mitigation strategies, and project milestones.
• Serve as a key point of contact for FDA communications, including submission of meeting minutes, responding to requests for additional information, and coordinating any teleconferences or follow-up discussions with the agency.
• Educate and advise cross-functional teams on evolving regulatory requirements and best practices specific to SaMD, clinical evidence generation, and AI/ML-based medical devices.

Future Submission Planning & Continuous Improvement:

• Anticipate and strategize for future regulatory submissions, such as 510(k), additional De Novo requests, or PMA supplements if product scope expands or new indications arise.
• Monitor relevant regulatory landscapes, guidance updates, and industry trends in digital health, AI/ML, and ultrasound imaging to inform long-term regulatory planning.
• Contribute to continuous process improvements, establishing scalable frameworks and templates for future submissions.

Qualifications:

Education & Experience:

• Bachelor’s or advanced degree in a relevant field (e.g., regulatory affairs, biomedical engineering, life sciences). Advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs, with a focus on software as a medical device and/or AI-based medical technologies.
• Proven track record of leading or supporting successful De Novo submissions, 510(k) submissions, or similar regulatory filings with the FDA.

Technical & Regulatory Knowledge:

• In-depth understanding of FDA regulations, guidance documents, and recognized standards applicable to SaMD (e.g., ISO 13485, ISO 14971, IEC 62304, FDA guidance on clinical decision support software, and AI/ML SaMD considerations).
• Familiarity with clinical validation requirements for imaging devices, including alignment with standard of care references (such as the Hadlock formula) and conducting subgroup analyses.
• Knowledge of data privacy, cybersecurity best practices, and software lifecycle documentation for regulated medical devices.

Soft Skills & Competencies:

• Strong project management skills with the ability to coordinate multiple external consultants and internal stakeholders to keep regulatory projects on track.
• Excellent analytical thinking, problem-solving, and decision-making capabilities.
• Outstanding verbal and written communication skills to translate complex technical and regulatory concepts into clear, actionable guidance.
• Ability to work autonomously in a fast-paced, evolving environment and adapt to changing regulatory expectations.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC) or equivalent.
• Experience with AI/ML algorithm validation, performance metrics, and clinical evidence generation.
• Prior involvement with FDA interactions, meeting minutes preparation, and successful agency communication.

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