Amit A.

About Amit A.

Medical device clinical strategy and regulatory affairs leader with 15+ years of experience leading global programs and portfolios across Class II and medical devices, including surgical robotics, navigation systems, and AI-enabled medical device software. Proven track record delivering EU MDR remediation and CE marking for 120+ products, sustaining 50+ Post-Market Clinical Follow-Up (PMCF) plans, and supporting FDA 510(k) submissions to maintain global market access. Deep expertise in post-market surveillance, regulatory compliance, and clinical evidence generation. Recognized for designing and scaling Real-World Evidence (RWE) and Real-World Data (RWD) strategies, including cost-efficient global data collection programs that reduced clinical evidence costs by 50% while meeting regulatory and quality standards. Strong background in portfolio program management, cross-functional leadership, and Key Opinion Leader (KOL) engagement, partnering with R&D, Regulatory Affairs, Health Economics & Market Access, Quality, and Commercial teams to accelerate time-to-market while ensuring patient safety. Known for executive-level communication, operational excellence, and the ability to translate clinical, regulatory, and data strategy into measurable business and market outcomes.CORE COMPETENCIESClinical Strategy | Regulatory Affairs | Global Regulatory Strategy | EU MDR & CE Marking | FDA 510(k) Submissions | Post-Market Surveillance (PMS)| PMCF Strategy & Execution | Real-World Evidence (RWE)| Real-World Data (RWD)| Program & Portfolio Management | Market Access Enablement | KOL & Advisory Board Engagement | Cross-Functional Leadership | Data Analytics | Process Optimization

Experience

1. Program Manager, Clinical Strategy, Enabling Technologies

   Medtronic

   Aug 2023 — Present

   Lead the clinical strategy for a portfolio spanning surgical robotics, navigation, and AI-enabled medical device software, aligning business roadmap with global evidence strategy.• Directed successful FDA 510(k) submission using Real-World Evidence, expanding navigation indications, and accelerating market adoption and growth of the surgical navigation portfolio.• Established a cross-functional PMCF training program, now adopted across Clinical and Regulatory functions to standardize clinical documentation under EUMDR.• Partnered with Health Economics & Reimbursement to develop Value Summaries supporting market adoption and growth investment decisions for next-generation navigation-imaging systems.• Designed an end-to-end medical imaging acquisition framework, improving approval readiness and enabling faster progression from R&D to regulatory submission.• Streamlined Clinical–Regulatory operating models, improving deliverable predictability and supporting on-time global approvals

Education

• Savitribai Phule Pune University

  BS, Mechanical Engg

  1992 — 1996

• Clemson University

  MS, Bioengineering

  2001 — 2003

• Cleveland State University

  PhD, Biomedical Engineering

  2004 — 2010

• Deutsche Auslandshandelskammern (AHK), Berlin / Indo-German Chamber of Commerce (IGTC), Mumbai

  Diploma, Marketing, Human Resources, Finance and Costing, Production

  1997 — 1999

Skills

• Characterization
• Medical Devices
• Clinical Research
• Stem Cells
• Tissue Engineering
• Design of Experiments
• Life Sciences
• Microscopy
• Medical Writing
• Bioengineering
• Polymers
• Technology Transfer
• Biomechanics
• Cell
• Data Analysis
• Biomedical Engineering
• Regenerative Medicine
• Biomaterials
• Animal Models
• Research
• Fluorescence Microscopy
• Mechanical Testing