Remote Senior SaMD QA Engineer — FDA Submissions

Adeptsource; United States; À distance; USD 140 000 - 180 000; Plein temps

Résumé du poste

Adeptsource seeks a senior software compliance consultant to drive regulatory alignment for our medical device SaMD products. You will lead software validation, risk management, and design controls, partnering with product management, regulatory affairs, software systems engineering, operations, and quality to ensure FDA and ISO compliance.

This six-month remote engagement in the United States requires deep experience with FDA submissions (510(k)/PMA), IEC 62304, ISO 13485, and a proven track

Qualifications

• 10+ years in the medical device industry with strong knowledge of software validation practices, quality systems, regulatory submissions, and compliance requirements for a medical device (e.g., ISO 13485, IEC 62304).
• Deep knowledge of FDA regulations (21 CFR Part 820) for design controls and quality systems.
• Experience with HIPAA and FDA cybersecurity guidance on software risk controls and interoperability.
• Experience with ISO 14971 risk management and IEC 62304 lifecycle.
• Experience with FDA interactions (510(k), PMA) and inspections.
• Experience with Usability / Human Factors validation.
• Audits of ISO 13485 or FDA inspections is a plus.

Responsabilités

• Support product development per the software development life cycle, including adherence to requirements management, design, and development.
• Collaborate with cross functional teams to integrate bioinformatic and software innovations into diagnostic tools and workflows.
• Support the development and validation of algorithms and software solutions for medical device applications, ensuring compliance with regulatory and quality standards.
• Develop and implement software validation strategies including risk management per FDA, ISO, IEC 62304.
• Oversee system architecture and validation docs (plans, protocols, tests) to ensure regulatory compliance.
• Oversee software risk management (hazard analysis, risk assessment).
• Maintain lifecycle documentation (design specs, tests, risk analyses, traceability).
• Prepare tech docs and regulatory submissions (510(k)/PMA) and participate in FDA interactions.
• Act as SME in audits/reviews with authorities and partners; co-lead gap resolutions.
• Manage backlog prioritization based on roadmap and user needs.
• Support Human Factors testing and risk assessment per IEC 62366-1 and ISO 14971.

Connaissances

FDA submissions

Regulatory compliance

Software validation

Risk management

HIPAA compliance

Cybersecurity

ISO 14971

Quality systems

Cross-functional teamwork

Medical device

Formation

BS/MS in software

Description du poste

Adeptsource seeks a senior software compliance consultant to drive regulatory alignment for our medical device SaMD products. You will lead software validation, risk management, and design controls, partnering with product management, regulatory affairs, software systems engineering, operations, and quality to ensure FDA and ISO compliance.

This six-month remote engagement in the United States requires deep experience with FDA submissions (510(k)/PMA), IEC 62304, ISO 13485, and a proven track