Pavan Kumar Malwade

About Pavan Kumar Malwade

Strategic and people-centric Regulatory Affairs and Quality leader with 16+ years of global experience driving market access, compliance, and innovation across Class medical devices, imaging systems, implants, combination products, AI/ML and SaMD.I have successfully led and scaled diverse RA/QA/Clinical teams across the US, EU, India, and APAC—strengthening talent pipelines, fostering collaborative, psychologically safe work cultures, and aligning cross-functional partners across R&D, Engineering, Clinical, Quality, and Product organizations. I specialize in translating rapidly evolving regulations (FDA, EU MDR/IVDR, CDSCO, TGA, PMDA, MFDS) into practical, growth-oriented strategies that accelerate approvals, protect revenue, and support digital transformation. I have a consistent track record of zero-major-NC outcomes across FDA, ISO 13485, and MDSAP audits, achieved through strong governance, risk anticipation, and first-time-right execution.Across my recent roles, I have led global strategies for multimillion-dollar portfolios, implemented Good Machine Learning Practices, navigated complex 510(k) pathways, executed MDR remediation for high-risk portfolios, and shaped digital health policy through GHWP committees and global industry forums. I take pride in driving QMS transformations, elevating organizational capability, and modernizing regulatory operations using digital tools, AI, and data-driven insights.With deep expertise spanning design control, risk management, clinical evaluation, cybersecurity, and AI/ML governance, I help organizations confidently bring innovative technologies to market while ensuring patient safety and strengthening compliance maturity.

Experience

1. Sr Regulatory Affairs Program Manager

   Philips

   Jan 2026 — Present

Education

• Swiss School of Business and Management

  Global Doctor of Business Administration (DBA), Adoption of AI-based tools in medical imaging

• Amity University

  Master of Business Administration - MBA, Entrepreneurship & Leadership

  2017 — 2019

• Clinotek India

  Advanced Diploma, Clinical Research, Regulatory Affairs & Clinical Data Management

  2008 — 2009

• Visvesvaraya Technological University

  Bachelor of Engineering (B.E.), Bapuji Institute of Engineering & Technology (BIET), Biotechnology

  2004 — 2008

Skills

• Nda
• Clinical Trials
• Global Regulatory Compliance
• Auditing
• Regulatory Affairs
• Human Factors Engineering
• Quality Assurance
• Device Development
• Udi
• Cmc Regulatory Affairs
• Quality System
• Product Lifecycle Management
• Ich-Gcp
• Biosimilars
• Pharmacovigilance
• Gmp
• Cmc
• Anda
• Ich-Quality Guidelines
• Health Product Software
• Formulation
• Regulations
• Iso 13485
• Usability Engineering
• Technical Documentation
• Medical Devices
• Clinical Research
• Capa
• Ctd
• Regulatory Submissions
• Combination Products
• Medical Device R&D
• Strategic Planning
• Biotechnology
• Human Factors
• Ce Marking
• Dossier Preparation
• Change Control
• Life Sciences
• Project Management