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

Role: Lead global regulatory strategy for digital health, biomarkers, and diagnostics within biopharma, supporting development and commercialization. Responsibilities: develop and execute regulatory strategies, provide guidance on requirements, partner with regional teams for lifecycle management, ensure compliance with global regulations (FDA, EMA, EU MDR/IVDR), influence cross-functional and external stakeholders, and promote continuous process improvement. Qualifications: Bachelor’s in a scientific discipline; advanced degree (PhD, MD, PharmD, MS) preferred; minimum 5 years in regulatory affairs, with experience in medical devices, diagnostics, or digital health; proven success in regulatory interactions and strategy development for device and digital health products; deep knowledge of global device development, registration, and post-market requirements. High-Value: expertise in biomarker strategies, device submissions (510K, CE Mark, BLA, NDA, IMPD, IDE, etc.), and understanding of regulation across major markets; experience with innovation in technical areas and global health authority engagement. Work setup: Remote within the US; no travel specified.