San Francisco Bay Area In Person Event: Elevate Your Career Journey: Speed Mentoring Session for Reg

Registration Fees & Deadlines

Learning Objectives

• Gain insights into industry trends and emerging technologies in regulatory affairs and quality management.
• Receive personalized career advice and guidance tailored to your professional goals and aspirations.
• Develop strategies for advancing your career in regulatory affairs or quality management.
• Expand your professional network by connecting with experienced mentors and peers in the field.

Who Should Attend?

This event is ideal for professionals at all levels of experience in regulatory affairs, quality management, compliance, and related fields. Whether you're just starting your career or seeking to enhance your expertise, this speed mentoring session offers valuable insights and networking opportunities to support your career growth and development.

Speakers

Jennifer Mascioli-Tudor
Host, Panel Speaker and Mentor

Jennifer is an experienced leader, who brings more than 20 years of industry experience in Quality and Regulatory leading global teams within the pharmaceutical and medical device industries. She has an extensive background in leadership and global quality assurance, regulatory affairs, and operational excellence.  Jennifer has progressed through several roles of increasing leadership responsibility working for companies such as Johnson and Johnson, Kyphon, Medtronic, Nevro, Boston Scientific, Outset Medical and GE Healthcare.  She is now Founder and CEO of JMT Compliance Consulting, LLC. where she is focused on partnering with small, emerging growth Medical Technology companies to drive Business/Quality/Regulatory strategy and Operational excellence initiatives.  Jennifer is passionate about building energized, diverse, and inclusive teams, focused on driving operational excellence and proactive quality and regulatory strategies, who are motivated by a shared mission to transform healthcare.

Jennifer is actively involved in the RAPS-SF Chapter, is part of the MedtechWOMEN and WOMEN Unlimited Mentorship Programs and is an instructor for the Regulatory Affairs for Medical Devices certificate program at UC San Diego.  Jennifer holds a BS in Physiology and Chemistry from Eastern Michigan University and an MBA from University of Phoenix.

Yoshiko Stowell
Panel Speaker, Mentor

Yoshiko Stowell, PhD, PMP is a Head of Regulatory Affairs at Neuron 23. She has over 19 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concept to global Phase III Clinical Studies and NDA/MAA approval for the treatment of CNS disorders, pain management, and rare diseases.  

Yoshiko is a RAPS-SF Chapter Chair. She is also a Women in Bio (WIB) SF Chapter Chair of the Communication Committee and President of Regulatory Affairs Toastmasters (RAT) club.  Yoshiko holds a BS in Chemistry from Tokyo University of Science, MS in Chemical Engineering from University of Oklahoma, and PhD in Pharmaceutical Science from University of the Pacific.

Peggy McLaughlin
Panel Speaker, Mentor

Peggy McLaughlin currently serves as a Strategic Clinical and Regulatory Advisor with the Fogarty Innovation Group.  Ms. McLaughlin is a veteran medical device professional with over 30 years of experience in both start-up and large commercial organizations.  She has managed clinical studies and authored regulatory submissions leading to CE mark, 510(k) and de novo petition clearances for products across a broad spectrum of clinical areas.  She has particularly deep experience in First in Human clinical studies and de novo petition submissions for novel medical products.  In addition to her work at Fogarty Innovation, she runs a consulting business in clinical and regulatory affairs, serves as a teacher and mentor to students in the Stanford Biodesign program, a reviewer for the National Evaluation System for health Technology (NEST) Coordinating Center and a member of the MDIC Predetermined Change Control Plan Advisory Panel.

Viswanathan (Vis) Ayer
Panel Speaker, Mentor

Vis currently serves as the Vice President of Regulatory Affairs and Global Quality at Nevro, bringing over 20 years of progressive experience in the medical field, with more than a decade dedicated to leadership roles in Global Quality and Regulatory Affairs. His notable achievements include establishing a robust QARA organization, securing regulatory approvals, and successfully navigating complex regulatory landscapes such as EUMDR and Brexit. Additionally, Vis has overseen the successful setup of new manufacturing facilities and managed quality system activities across all locations.

Vis holds a RAPS Executive Leadership certification from Kellogg School of Management, as well as an M.S. in Electrical Engineering from the New Jersey Institute of Technology and a B.S. in Electronics and Communication Engineering from Mepco Schlenk, India. Prior to joining Nevro, Vis held progressively responsible software engineering roles at Medtronic and Kyphon and served as a technical consultant at Taratec Development Corporation. In this capacity, he provided expert quality and regulatory guidance to address regulatory agency findings for notable companies including GE Healthcare, Emergent Biosolutions, Merck, and Cordis.

Mario Wijker
Panel Speaker, Mentor

Mario is a seasoned medical device industry leader with over 30 years of experience in quality and regulatory affairs. He is co-founder at Rarebit AI, a company that helps identify and resolve quality issues before they happen using advanced AI technologies within the medical product quality management system. He is also SVP Quality and Regulatory Affairs for Bio-Rad Laboratories. Mario also worked for companies such as Teleflex Medical, Mölnlycke Healthcare, Boston Scientific, Life Technologies, Applied Biosystems and Visible Genetics. He has been leading QARA organizations and created innovative strategies to drive quality culture in an organization as well as pragmatic transformation to ensure effective processes and motivated teams with a “patient first” mentality.

Location

Fogarty Innovation
2495 Hospital Drive
Suite 300
Mountain View, CA 94040

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.

Questions