Regulatory Affairs Specialist

Job Summary

Owning FDA compliance and leading the regulatory strategy for product development, the full-time remote Regulatory Affairs Specialist will manage the lifecycle of existing 510(k) clearances, maintain quality management systems, and oversee broader compliance initiatives including HIPAA and SOC 2.

Key responsibilities

• Manage the lifecycle of Archy Imaging's 510(k) clearance, including submissions and change assessments
• Oversee the Quality Management System and post-market program, ensuring compliance with FDA regulations
• Develop and implement regulatory strategies for new products, integrating compliance into the product development process

Required qualifications

• 5+ years of experience in regulatory affairs within medical devices, digital health, or healthcare SaaS
• Hands-on experience with the 510(k) lifecycle for SaMD or AI/ML-enabled software
• Strong understanding of relevant standards and frameworks, including 21 CFR Part 820 and IEC 62304
• Proven ability to operationalize compliance in a fast-paced environment
• Excellent written communication skills for drafting regulatory documents and internal policies