FDA Regulatory Specialist

Job Summary

To ensure regulatory compliance of Software as a Medical Device (SaMD) products across US and international markets, the full-time hybrid FDA Regulatory Specialist will manage FDA submissions, support global regulatory strategy, and maintain quality management systems.

Key Responsibilities

• Prepare and manage FDA submissions, including 510(k) and DeNovo pathways, ensuring completeness and compliance of all regulatory documentation
• Support development of US reimbursement strategies and ensure compliance with FDA, SOC2, and MDSAP requirements
• Maintain and improve Quality Management System (QMS) processes related to regulatory compliance and support audits

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Engineering, Regulatory Affairs, or related field
• 7+ years of experience in regulatory affairs with a focus on FDA submissions
• Experience with SaMD, ISO 13485, ISO 14971, and MDR compliance
• Knowledge of clinical studies and understanding of the US reimbursement landscape is a plus
• Experience with SOC2 / MDSAP is a plus