San Francisco Bay Area Chapter In-person Event: 2nd Annual Women in Leadership Summit

Women face unique challenges as we thrive in our career advancement and manage work life balance. Learn from women leaders in regulatory affairs and quality. Feel empowered and inspired to increase confidence in you. We invite women and allies to a dynamic panel discussion followed by a networking reception.

Registration Fees & Deadlines

Speakers

Kristin Ellis
Sr. Director of Global Regulatory Affairs, R3 Vascular

Kristin is a seasoned medical device Regulatory Affairs leader with over 26 years in the medical device industry. Her background in R&D engineering provides a product-centric experience in optimizing regulatory pathways, managing agency interactions, and ensuring global compliance across the product life cycle. Kristin has successfully led numerous FDA submissions, CE marking efforts, and global registrations spanning Canada, Australia, and Asia. She has extensive expertise in risk management, design and development, and quality systems, and serves as the primary liaison with regulatory bodies including the FDA and EU Notified Bodies. Kristin has held Regulatory leadership roles at R3 Vascular (current),  Imperative Care, Silk Road Medical, and Abbott Vascular Structural Heart (Evalve), where she contributed to the regulatory success of innovative Class II and Class III neurovascular and cardiovascular devices. Kristin also worked as a regulatory consultant for Stryker Neurovascular, Shockwave Medical, and a sleep apnea medical device start-up. Kristin holds a B.S. in Mechanical Engineering from the University of Washington, is RAC (US) certified, and is a member of the Regulatory Affairs Professionals Society (RAPS). She is also an inventor on multiple U.S. and European patents, underscoring her commitment to advancing medical technologies through innovation and regulatory excellence.

Michelle Wu
Founder & CEO, Nyquist AI

Michelle Wu is the founder and  CEO of NyquistAI. She has over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been recognized as the Top 100 Women in AI in 2025, featured by Forbes, and given talks on AI in life science in various conferences. She is book chapter author on AI in Healthcare by MIT Press.
 Before founding NyquistAI, she was the youngest global strategy manager at Novartis AG, where she worked on the very first and so far the only asset swap deal in the history of the pharmaceutical industry among Novartis, Eli Lilly, and GSK, which led her to realize the universal pain point of manual and cumbersome data research and potential pitfalls if it is not done right. This experience inspired her to build NyquistAI. Prior to Novartis, she worked for the life science practice for BCG and served big innovative pharmaceutical and Medtech companies on their global strategy, product development strategy, and emerging market strategies. She received her MBA from Stanford University and BA from Peking University. She speaks English, Chinese, Vietnamese, Japanese, and a bit of German, given her global work experience in Asia, Europe, and now the US.

Jeaneen Wallis, MBA PhD
CEO, Clinical Quality Lead | UCSC Silicon Valley Instructor

Dr. Wallis has been working in the clinical trials field since 1999. In the past she worked in Technical Operations & Vendor Management at Amgen and in Biosample Management and Global Clinical Operations QA at Genentech.

Most recently, she manages CQA programs focused on QMS design and implementation, vendor oversight, and risk management for a variety of biopharmaceutical and medical device sponsors. She is also an independent auditor or biopharmaceutical and medical device sites and service providers.

She holds B.A. degree from Pomona College in Science, Technology and Society, and an M.B.A in Global Management and Ph.D. in International Psychology focused on Organizations and Systems.

She currently is an instructor for UC Santa Cruz-Silicon Valley and the Parenteral Drug Association. Currently Dr. Wallis leads her consulting company but is also working on her next venture which is to start a software company delivering systems and services to help researchers, operations and quality teams.

Divya Yerraguntla
Chief Client Officer, InoRX

An established leader and influencer in the Pharmaceutical industry, Divya has been in the industry for more than 25 years, working with companies such as Johnson & Johnson, Novo Nordisk, SUN Pharma, and Syneos Health. She is a seasoned Speaker and chairperson of various Pharmaceutical Forums and Conferences, an Angel investor with LSA, an Advisor for Biotech startups, and a Board member. She is also the host of the “Woman to Woman” podcast series, which provides support and guidance to women professionals and executives.

She has extensive experience in Strategy Development, Commercialization, Pharmaceutical New Product Launch, Asset Strategy, Clinical Continuum, Lead Generation, and Sales. With more than 30 global product launches, she has a passion for operational aspects of mission-critical projects that maximize portfolio and positively impact patient lives.

Honey Dayani
Manager, Label Design and Development, Intuitive Surgical

Honey Dayani is a Manager, Label Design and Development at Intuitive and has over 15+ years of experience working in Medical Device Industry. Honey manages Label Design and Development team and supports label artwork design & development across all Business Units at Intuitive.  With the constant changes in the regulatory requirements for labeling, Honey’s team is continuously evaluating the best ways to navigate and implement the changes to the artwork in an efficient way. Honey has vast experience in Quality, Regulatory Operations and Reg Compliance leading successful external audits. She is passionate about leading teams, empowering people and improving patient’s lives. Honey lives in the Bay Area, California with her two children and a husband. She enjoys cooking and practicing Yoga Nidra technique (guided meditation).

Mihikaa Jain
Chief of Staff, Artos AI

Mihikaa Jain leads Product Strategy and Customer Success at Artos, a Y Combinator–backed AI company focused on regulatory document authoring for life sciences. She brings a rare blend of product leadership, regulatory domain knowledge, and commercial strategy to the intersection of AI and healthcare.

At Artos, Mihikaa plays a pivotal role in bridging the gap between technical and non-technical teams. She works closely with regulatory affairs professionals to understand real-world user needs and translates those into actionable product requirements—shaping the company’s roadmap and ensuring engineering efforts are aligned with business priorities.

Mihikaa began her career at Bain & Company, where she advised Fortune 500 companies and SaaS startups on product roadmap design, pricing and packaging, and M&A integration. She later joined Mekonos, a cell and gene therapy platform company, where she closed its first commercial deal and built partnerships with leading biopharma organizations.

Mihikaa holds a Master’s in Translational Medicine from UC Berkeley and UCSF and a Bachelor’s in Biological Sciences and Bioengineering from IIT Kanpur. She is an active member of the RAPS SF community, where she has helped organize local events and contributed to ongoing discussions on AI adoption in regulatory workflows.

Surina Gulati
Quality Systems Engineering Lead, iRhythm Technologies Inc. | UCSC Instructor

Surina is a Quality Systems Engineering Lead at iRhythm Technologies with more than eight years of experience in quality, regulatory compliance, and digital health within the medical device industry. She is an Exemplar Global–certified Lead Quality Management Systems Auditor and an adjunct instructor and Advisory Board member for the Regulatory Affairs and Medical Device Quality & Design programs at UC Santa Cruz Silicon Valley. Her published work includes contributions to Fundamentals of Medical Device Regulations: A Global Perspective and multiple industry articles on regulatory best practices.

Her professional background spans roles at Align Technology, a Stanford StartX AI/ML start-up, and Thermo Fisher Scientific. Surina holds an MS in Biotechnology & Entrepreneurship from Johns Hopkins University and a BS from the University of California, Berkeley. She was honored with the RAPS Rising Star Award in 2024.

Sponsors

USSC

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions