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Clinical Informatics Regulatory Lead
Philips
Bengaluru +1 · Hybrid, 3 days in the officeLead (10+ years)Full-timePosted 5 days ago
About the job
What you'll do
Lead global regulatory strategy and execution for a portfolio of AI-enabled healthcare software and clinical informatics solutions. Partner with cross-functional teams including R&D, Quality, and Product Management to drive regulatory pathways, submissions, and market access.
What they're looking for
Requires a Bachelor's or Master's degree in a relevant field and over 8 years of regulatory affairs experience in medical devices or IVDs. Mandatory expertise includes SaMD, AI/ML-enabled products, cybersecurity, and global regulatory frameworks like FDA and EU MDR.
Full description