Director of Regulatory Affairs

Job Summary

A company is looking for a Director, Regulatory Affairs and Quality Assurance.

Key Responsibilities

• Lead regulatory and quality strategy for product development and lifecycle management
• Ensure compliance with FDA, CE (MDR), and other global regulatory frameworks
• Oversee post-market surveillance, adverse event reporting, and regulatory audits

Required Qualifications

• Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred
• 8+ years of regulatory affairs experience in medical devices or digital health
• Proven track record of successful FDA submissions and international regulatory approvals
• Deep understanding of software as a medical device (SaMD) and cybersecurity regulations
• Experience with privacy and data regulations (e.g., HIPAA, GDPR)