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Edda Technology
Princeton, NJ (In Person)
Full-Time
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Job Description
Primary Responsibilities Princeton, NJ 08540 Regulatory Affairs Preparation and execution of regulatory submissions, including FDA 510(k) submissions, software modifications, and international registrations as applicable. Assess regulatory impact of software, AI/ML, cybersecurity, and product changes. Develop regulatory strategies and recommendations for new products and software upgrades. Support interactions with FDA, notified bodies, regulatory consultants, and international regulatory agencies. Monitor evolving regulatory requirements and communicate potential impacts to the organization. Support regulatory assessments related to design changes, risk management, verification, validation, and clinical evidence. Clinical Affairs & Hospital Collaboration Support preparation and submission of IRB applications, clinical study protocols, investigator documentation, study reports, and publications. Coordinate collaborations with hospitals, physician investigators, and academic research partners, and assist in organizing collaboration activities. Work closely with investigators and research coordinators to facilitate study execution, data collection, and project tracking. Support development of clinical evidence for regulatory submissions, publications, and product validation. Cross-Functional Collaboration Partner closely with engineering teams to ensure regulatory requirements are incorporated throughout product development. Collaborate with product management, marketing, clinical, and quality teams to support successful product commercialization. Independently manage multiple regulatory and clinical projects while maintaining schedules and deliverables.