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Over 30 highly regulated products launched. Over $2 billion in revenue generated for some of the biggest names in health and life sciences, including Gilead, Roche, and Boston Scientific. That’s the kind of impact I’m passionate about making.My journey into healthtech, product management, and digital transformation started when I navigated the complex maze of paperwork to secure benefits for my mother after she became disabled. I saw firsthand how convoluted systems can overwhelm those who rely on them, and I was driven to create change.I began my career managing regulatory filings and compliance programs in medtech and biopharma, seeing an opportunity to bring operational excellence and innovation to a field often mired in complexity. By embedding compliance and governance into the digital DNA of products from the start, I realized I could streamline even the most intricate systems—turning compliance from a blocker into an enabler of user-friendly, impactful digital experiences.I’m proud of results like helping Gilead (NASDAQ: GILD) unlock $81 million in revenue, achieving a 57% ROI for Labcorp (NYSE: LH), realizing 65X ROI on AI implementation for a venture-backed startup, and accelerating a life-saving product to market two months faster. Each success reinforced my belief that with the right strategy, even complex regulatory and compliance needs can support digital transformation goals.Today, I’m focused on creating products that work for people, not against them. By integrating compliance at every stage, I help companies drive meaningful impact, enhance user experience, and achieve operational success.Values: Bravery, Honesty, Fairness, PerseveranceClifton Strengths: Relator, Futuristic, Analytical, Ideation, StrategicSuperpowers: Creating clarity, Decisiveness, Pattern Mapping, GritSuperskills: Digital Strategy in Regulated Environments, Product Development, Cross-Functional Leadership
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AdvisorVahana Labs AiSan Francisco, Ca, Us -
Vp Of Product And ComplianceKorio, Inc. Mar 2022 - PresentDoylestown, Pa, Us--Led AI and digital transformation strategy across commercial, R&D, and client services, achieving 65X ROI on AI initiatives.--Led the strategic delivery of an MVP, securing a top 5 biopharma customer and driving long-term growth through digital innovation, positioning the company for sustained market success and transformation.--Defined and executed a strategic framework for a B2B SaaS clinical trials supply chain startup, driving innovation and operational scalability.--Developed data and governance strategies to automate complex clinical trial protocols, improving efficiency and compliance.--Served as interim Head of Engineering, driving coding standards, architecture, and scalable digital solutions.--Oversaw cross-functional teams of 50+ across Product, Engineering, DevOps, IT, and Compliance, fostering a high-performance culture and operational excellence.--Transformed Professional Services and Customer Support organizations through operational optimization, KPI development, and strategic alignment with digital goals.--Led five international contracting teams, driving execution and alignment across Armenia, Pakistan, India, and Brazil.--Conducted critical "build vs buy" assessments and technical due diligence, enhancing investor confidence and driving customer acquisition.--Created board presentations and sales collateral to communicate digital transformation initiatives and compliance strategies, driving stakeholder engagement.Background: B2B SaaS w with AI; eClinical Supply Chain; highly configurable software for clinical trial supply chain. As employee #1 joined to launch product vision, strategy, and engineering for the design and architecture of the application and infrastructure. Built the company infrastructure and team, executed product design, helped secure customers, and established compliance policies for quality, privacy, and security. -
Advisor To Portfolio CompaniesRedesign Health Aug 2023 - PresentNew York, New York, UsA VC studio portfolio companies that powers innovation in healthcare by developing technologies, tools, and insights that lower the barriers to change across the industry. -
Vice President, Program ManagementClip Health Jun 2021 - Jan 2022
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Senior Director, Program ManagementClip Health May 2020 - Jun 2021--Drove strategic pivot from STD to COVID testing, generating 250% growth in product revenue. --Worked directly with the CEO to define product vision, strategy, OKR framework, and roadmap.--Worked with 40+ internal & external stakeholders to pilot & launch products--Partnered with Data Science to set standards for responsible AI, accelerating product deployment by 30% and improving model accuracy by 15% to enhance user experience and reliability. --Established governance frameworks reducing review cycles 27% increasing release cadence. --Standardized engineering and manufacturing processes, achieving a 35% faster delivery speed and 20% cost reduction to scale production capacity in line with product demand. --Scaled the company from 8 to 130 with 90% retention, aligning talent strategy with growth objectives and preparing for Series B funding.--Led and managed team of 10, navigating through a RIF with 100% retention of high performers. --Partnerships included: NIH RADx, Sanofi, eMedA Series B, B2B hardware, software, & AI company that provides in vitro diagnostics; supported by Y Combinator and Khosla Ventures; won the National Institutes of Health RADx challenge. Promoted to right-size the title to better align with the role after supporting growth from Seed to Series B, and from 8 to 130 employees.
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Senior Director, Program ManagementEndpoint Clinical Jun 2019 - May 2020Wakefield, Massachusetts, Us -
Director, Program ManagementEndpoint Clinical Feb 2018 - May 2019Wakefield, Massachusetts, Us--Launched internal product scaling compliance automation by 32%, leading to 18% faster audit cycles, a 57% ROI, and 4x team growth with 0% turnover. --Led a 20 person global product compliance team--Launched 2 product updates across 3,000+ B2B applications. --Led COGS optimization, achieving a 20% cost reduction by setting OKRs that aligned product and departmental goals. --Elevated board engagement with product-driven risk presentations, enabling faster decisions on compliance and security that impact product market readiness. --Defined a data strategy with IT and R&D, reducing data errors by 30% and accelerating delivery timelines by 25% to meet product milestones.--Clients included: Moderna, Bristol-Myers Squibb, AbbVie, Takeda, Roche/Genentech, GileadA 500-employee B2B SaaS, AI, and eClinical Supply Chain product and a subsidiary of a public, Fortune 500 company. Promoted to right-size the title; reported to the CEO of endpoint and dotted line to the CISO and CPO of Labcorp, a 65,000-employee business.
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Director, Program ManagementVineti Feb 2017 - Jan 2018San Francisco, California, Us -
Director, Program ManagementVineti Aug 2016 - Feb 2017San Francisco, California, Us--Aligned OKRs with product goals, boosting release cadence by 40%, enabling a two-month early launch, and driving $81M in additional revenue for Gilead. --Partnered with sales by creating targeted white papers, raising client engagement by 25%. --Presented comprehensive product and corporate risk management strategies to the Board, proactively addressing critical quality, regulatory, privacy, and security risks. --Scaled the company from 3 to 70 employees, fostering an Agile quality-driven culture. --Led test engineering and SaaS validation efforts, reducing security vulnerabilities by 50%.--Clients included: Novartis, Gilead, Johnson & Johnson, Red Cross of AmericaA Series B, B2B SaaS, cell therapy supply chain company funded by GE Ventures, DFJ, Canaan, and Threshold. Promoted to take over additional responsibilities as the company grew rapidly; led privacy and security.
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PrincipalTripati Strategies Jun 2009 - Jan 2018
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Director, ProgramsAlivecor Jul 2015 - Jul 2016Mountain View, Ca, Us--Delivered 8x revenue growth along with increasing margin by over 2x. --Expanded EU market reach and integrated with Apple Watch, increasing accessibility by 30%. --Scaled production 27X by relocating manufacturing to China, maintaining quality and reducing supply chain costs by 15%. --Defined responsible AI model standards with Data Science to streamline FDA submissions, reducing preparation time by 22% for faster product approval. --Defined and analyzed product metrics to identify improvement opportunities, cutting customer service expenses by 7% and improving response times by 15%. --Defended against FDA inspection post-recall, restoring regulatory trust and avoiding penalties. --Established privacy and security functions, reducing data breach risk by 40%.--Partnerships included: Omron, GE Healthcare, LifewatchA B2B & B2C cardiac monitoring device company with hardware and software led by AI with growth from Series B to Series C. Backed by Khosla Ventures and WP Global. -
Manager Regulatory ComplianceAccuray Sep 2014 - Jul 2015Madison, Wi, UsA public B2B 1100-person medical device company focused on capital radiation oncology and radiotherapy equipment, with hardware and software using AI for surgical robotics. Hired to lead the audit function.- Planned, coordinated, and executed regulatory compliance audit program for the global organization, including locations in Japan, China, Hong Kong, Switzerland, and the US; developed and implemented the structure for the global quality system and global quality policies and procedures. - Worked with global R&D, manufacturing, service, and commercial organizations to audit sites for compliance; addressed audit non-conformities; and developed inspection response and training.- Established the regulatory intelligence process.- Defended against an FDA inspection to support the queries and ensured no findings. -
Global Quality Assurance ManagerCoopervision Jan 2013 - Aug 2014San Ramon, California, UsA public Fortune 1000 B2B and B2C medical device subsidiary of The Cooper Companies focused on developing & commercializing soft contact lenses. Planned and coordinated regulatory compliance audits as part of a system gap analysis; developed structure for global quality system and global quality policies and procedures and implemented the structures. Worked with global logistics and commercial organizations at various sites to develop instructions for compliance with global policies. Served as Management Representative for OUS, OEU, and O-Japan sites, HSA, and registrar audits. - Developed qualification policies, procedures, and requirements agreement template for selection & evaluation of contract design, manufacture, logistics, and distributors; audited vendors and oversaw remediation plans.- Developed an internal Global Complaints Capture system to ensure the consistent and timely reporting of complaints; collaborated with IT to integrate salesforce CRM and Oracle EQMS, linked complaints reporting tools.- Worked with Global QA and Commercial Operations to develop a recall handbook and templates.- Participated in the development of a Warning Letter response for our Puerto Rico manufacturing facility. -
Quality Engineer Iii (Promoted From Qe Ii)Stellartech Research Jul 2010 - Dec 2012Milpitas, Ca, UsPrivately owned medical device contract manufacturer focused on radio frequency capital equipment and disposables.- Quality Systems Development: Reviewed applicable standards, developed strategy, negotiated implementation, and provided training. Completely revamped and designated process owner for CAPA, Process Validation, Sterilization Controls, Risk Management, and Design Controls procedures. - Reviewed and approved product specifications, hardware/software requirements, software architecture, and software design documents. Assisted in the development of verification and process validation protocols. - Created, submitted, and defended technical files; created and revised sections of 510k submissions.- Led internal audit program, including selection, qualification, and supervision of audit team and reported results to management. Responded to audit findings. -
Quality EngineerAutonomic Technologies, Inc Sep 2009 - Jun 2010A small, privately owned start-up medical device company focused on implantable neurostimulation systems.- Collaborated with R&D to develop system, product, and mechanical verification; process qualification; and system validation plans. - Led the team and the development of risk documentation. - Worked with contract manufacturers and component suppliers to improve performance and produce auditable documentation including device history records and manufacturing instructions.
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Quality Engineer (Promoted From Qa Associate)Acumen Medical Feb 2008 - Jun 2009Us -
Customer Service Representative/Clinical Research AssociateEvera Medical Jun 2007 - Sep 2007Us -
Senior Typist ClerkCity Of Burlingame Jun 2005 - Jun 2007Us
Arvita Tripati, Mba Skills
Arvita Tripati, Mba Education Details
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Carnegie Mellon University - Heinz College Of Information Systems And Public PolicyArtificial Intelligence -
Advanced Ai Product Management & LeadershipAi Product Management & Leadership
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Harvard T.H. Chan School Of Public HealthWomen On Boards
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Startup School Online
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IappEu Data Privacy And Privacy Program Management
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Babson F.W. Olin Graduate School Of BusinessMarketing
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University Of California, Santa CruzRegulatory Affairs
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University Of California, Santa CruzEuropean Intellectual History
Frequently Asked Questions about Arvita Tripati, Mba
What company does Arvita Tripati, Mba work for?
Arvita Tripati, Mba works for Vahana Labs Ai
What is Arvita Tripati, Mba's role at the current company?
Arvita Tripati, Mba's current role is Advisor.
What is Arvita Tripati, Mba's email address?
Arvita Tripati, Mba's email address is at****@****cal.com
What is Arvita Tripati, Mba's direct phone number?
Arvita Tripati, Mba's direct phone number is +165072*****
What schools did Arvita Tripati, Mba attend?
Arvita Tripati, Mba attended Carnegie Mellon University - Heinz College Of Information Systems And Public Policy, Advanced Ai Product Management & Leadership, Harvard T.h. Chan School Of Public Health, Startup School Online, Iapp, Babson F.w. Olin Graduate School Of Business, University Of California, Santa Cruz, University Of California, Santa Cruz.
What are some of Arvita Tripati, Mba's interests?
Arvita Tripati, Mba has interest in Imbibing Bourbon, Kayaking, Scuba Diving, Quilting Social, Sailing, Cooking (French And Italian), Active, Running Domestic, Adventure Travel, Enjoying Fine Dining Restaurants.
What skills is Arvita Tripati, Mba known for?
Arvita Tripati, Mba has skills like Iso 13485, Fda, Quality System, Medical Devices, Capa, V&v, Quality Assurance, Design Control, Quality Auditing, Cross Functional Team Leadership, Iso 14971, Root Cause Analysis.
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