Jay Shah
Chief Medical Safety Officer, VP of Clinical Oversight and Innovation @ iRhythm Technologies, Inc.
About
I build enterprise medical safety and clinical oversight systems that scale—from startup to public‑company. A cardiologist by training, I combine deep healthcare delivery and leadership with builder DNA (launched/led programs at Portland Clinic and served as CMO of an AI‑driven startup) and the credibility to execute in cross‑functional, matrixed environments at scale. At iRhythm Technologies (NASDAQ: IRTC), I lead Enterprise Medical Safety & Global Clinical Oversight across SaMD/device and service—partnering with RA/QA, ClinOps, Product, Compliance/Legal, and Commercial to strengthen regulatory defensibility, post‑market medical safety, clinical governance across a global service footprint, MLR, compliance process redesign, to drive operational excellence for internal stakeholders, customers, and patients.
United States
Boston
Hospital & Health Care
Global Clinical Service Oversight, Governance, and Excellence, Medical Device (SaMD & Device) Safety, Vigilance, and Post-market Surveillance, Medical Device Safety, Innovation Consulting, Startups, Strategic Leadership, Interpersonal Skills, Regulatory Strategy Development, Global Strategy, Design Collaboration, Product Vision, Key Opinion Leaders, Advisory Boards, Cross-team Collaboration, Marketing Strategy, Lead Generation, Business Development Strategy, Fundraising, Problem Solving, Risk Assessment
Experience

Chief Medical Safety Officer, VP of Clinical Oversight and Innovation
Boston, Massachusetts, United States
► Integrated enterprise medical safety governance from product development to post‑market surveillance; partnered with RA/QA to mature risk files, and provide medically grounding for submissions and post-market activities. ► Created and operationalized global clinical service oversight—embedding medical directors into Clinical Operations for education, engagement, and escalation pathways to lift technician quality, and reduce ambiguity. ► Stood up Clinical Oversight framework for UK/EU and Japan ► Led cross-functional redesign of off-label communication process to de-risk and streamline. ► Partnered with Commercial to engage national external stakeholders to align on risk/notifications protocols; supported site‑level process fixes to prevent recurrence.

Chief Medical Officer
Switzerland
At Aktiia, we're at the forefront of revolutionizing blood pressure management and understanding globally. Harnessing cutting-edge AI-powered algorithms on top of over hundreds of millions of data points collected from more than 60,000 active users across the globe, we foster breakthroughs in understanding of blood pressure and precise and personalized medicine for the world's most common disease. CE-marked as a Class II approved medical system in 7 markets and approved in 44 countries worldwide. We continue to accelerate our efforts to achieve better health for the world.

Independent Advisor
Engaged in seed rounds through late-stage pre-IPO investments in companies such as Innovega, Reliant Immune Diagnostics/MDBox, Monogram Orthopedics, Tradefox, Gryphon, Palantir, SpaceX, Circle, Virgin Hyperloop One, 23 & Me, DocuSign, Lyft, Pinterest, NowRx, Asombroso Tequila, MicroSalt, and Elucid Bioimaging. ► Held advisory board positions and consulting roles, making significant contributions to various organizations. Notably, provided medical expertise, strategic insights, and acted as the face of MicroSalt, fostering connections with VCs and non-profits. Collaborated with Innovega (providing strategy advice, investor relations support, and exploring medical applications with VCs), and Elucid Bioimaging (offering medical expertise, strategic insights, and consulting on clinician-focused design interfaces). ► Mentored aspiring healthcare entrepreneurs as part of the Mayo Clinic/ASU MedTech Accelerator Program, providing invaluable guidance and support in navigating the dynamic landscape of the healthcare industry.

Senior Medical Director
Phoenix, Arizona Area
Established the groundbreaking National Center for Excellence for Aortic Diseases, transforming the landscape of care for thoracic aortic diseases with a multidisciplinary approach. Built a comprehensive and visionary care model, assembling a collaborative, synergistic team across seven service lines to deliver exceptional patient outcomes and experiences. ► Led with exceptional leadership and strategic insight, successfully treating and managing over 600 patients with complex thoracic aortic disease within a brief two-year period, setting a standard for excellence. ► Engineered a remarkable increase in internal surgical volumes, achieving a 2x growth within a year. ► Navigated the complexities of international healthcare, spearheading the development of an enterprise-level international patient program. ► Mentored and advised residents, fellows, and medical students, guiding their professional growth and development as a senior faculty member. Led core cardiology teaching services, delivering tailored educational programs to trainees at all levels.

Executive Board
Portland, Oregon Metropolitan Area
Led transformative process over five years, establishing a new standard for board engagement and earning recognition as a dynamic "change agent." Key accomplishments include: ► Formulated mission and vision, selected new leadership team, redesigned compensation and benefits, optimized finances, and revamped real estate utilization. ► Achieved impressive 25% revenue growth and 20% expense reduction, ensuring financial sustainability. ► Shaped review and redesign of real estate/space utilization including consolidation, planning, financing, and development and construction of two new practice sites.

Medical Director
The Portland Clinic
Portland, Oregon Area
Pioneered an innovative model for the cardiovascular service line, aligned with triple aim goals and value-based contracts, delivering exceptional care, excellent patient experiences, and cost reduction. ► Transformed an unprofitable service line into a thriving multimillion-dollar profit center, contributing 10% of total organizational revenue. ► Led recruitment, management, and development of the cardiovascular team, fostering a culture of excellence and collaboration. ► Negotiated equipment purchases and leases, optimizing resources and securing cutting-edge technologies. Established full-time imaging labs to enhance diagnostic capabilities and patient care. ► Implemented a digital reading and reporting platform for monitors, graphics, and devices, streamlining workflows and improving efficiency in interpreting and reporting cardiovascular data.
Education
Jay Shah's Contact Information
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