Amy J. Phillips

• Lead clinical affairs and regulatory strategy for product development and IDE trials; manage FDA correspondence, annual IDE reporting, and site/IRB/CRO relationships across three U.S. clinical sites.
• Oversee clinical monitoring, data integrity, and patient safety; execute global audits and close-out activities; authored two clinical investigation reports submitted for FDA market clearance.

• Advise medtech and digital health clients on regulatory pathways (510(k), IDE), commercialization strategy, sales enablement, and clinical evidence generation.
• Mentor leadership and sales teams to institutionalize training, scalable commercial processes, and reimbursement strategies to accelerate adoption in regulated markets.
• Lead partner negotiations, go-to-market planning, and investor-facing commercial diligence.

• Developed vision, operations, and go-to-market plan for retail sleep business; managed 6-member team and delivered 95% customer satisfaction and 85% CPAP adherence.
• Negotiated payer/provider contracts and designed care pathways to reduce comorbidity-driven costs; implemented performance metrics to align clinical and commercial objectives.

• Owned go-to-market strategy for a €250M portfolio in emerging markets; aligned commercial, regulatory, and operational plans to enable sustainable expansion.
• Directed 30+ cross-functional team in India to lower production costs 30%; implemented China strategy achieving 43% segment growth.

• Managed integrated marketing and operations for $67M business; led 15+ member teams with P&L accountability, product launches, and clinical education programs producing 20–25% YOY growth.
• Led integration of acquired portfolios and implemented sales and clinical training to support field adoption.

Owned and operated a mobile pediatric medical diagnostics testing company for 11 years.