Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health

Role: Lead global regulatory strategy for precision medicine and digital health programs, supporting development and commercialization across therapeutic areas. Responsibilities: develop and execute regulatory strategies, provide expert guidance on regulatory requirements, collaborate with regional teams for lifecycle management, ensure compliance with device and diagnostic regulations including EU MDR/IVDR, and influence external policy engagement. Lead internal and cross-functional initiatives, train teams, and monitor regulatory trends to adapt strategies. Qualifications: Bachelor's in a scientific discipline; advanced degree (PhD, MD, PharmD, MS) preferred; minimum 5 years in regulatory affairs, with specific experience in medical devices, diagnostics, or digital health. Proven success in device development, submissions (e.g., 510(k), CE Mark, BLA, NDA), and interactions with FDA, EMA, Notified Bodies. Expertise in biomarker strategies and regulatory landscape for precision medicine. Location: Remote US; salary range $154,400–$242,550. High-Value: focus on device/diagnostic submissions, global regulatory engagement, digital health, precision medicine, and biomarker integration.