Primary Responsibilities

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.