Global Regulatory Affairs Director

Job Summary

Providing strategic and tactical guidance, the full-time Associate Director of Global Regulatory Affairs will develop and lead global regulatory strategies for precision medicine and digital health initiatives while working remotely.

Key responsibilities

• Develop and lead global regulatory strategies for assigned precision medicine and digital health programs
• Identify regulatory requirements and provide guidance to global development teams on assigned projects
• Monitor regulatory trends and support lifecycle management activities to ensure compliance across markets

Required qualifications

• Bachelor's degree in a scientific discipline; advanced degree (PhD, M.D., PharmD, MS) preferred
• Minimum of 5 years of experience in regulatory affairs, particularly with medical devices and diagnostics
• Proven track record in developing regulatory strategies for digital health products and precision medicine
• Expert knowledge of device development and registration requirements
• Demonstrated success in interactions with global health authorities, including FDA and EMA