Connie P.

• Lead Regulatory Operations in the U.S. for Akili’s FDA-authorized digital therapeutic product (EndeavorRx®) • Lead and manage the Regulatory Affairs team - internal and external (i.e. contractors, consultants) • Lead and manage interactions with government(s) and regulatory pre-market applications (ex. Q-submissions, 510(k)s, de novo) • Develop regulatory strategies and implementation plans and feeds into cross-functional design and development teams • Ensure compliance with regulatory requirements and adheres to internal corporate policies and operating processes • Provide timely and clear updates on project timelines, deliverables, and issues. • Collaborate with multiple stakeholders in cross-functional teams. • Develop and maintain regulatory document archiving and tracking databases. • Develop and maintain current regulatory knowledge of regulations and guidelines. • Contribute in review and authoring of Standard Operating Procedures (SOPs), Work Instructions (WIs), templates.

• Lead Regulatory representative for Philips’ Precision Diagnosis (Diagnostic X-Ray) & MR Coils business units focused on Software as a Medical Device (SaMD) products while assisting with regulatory issues related to items such as labeling and marketing ideas, preparing documents required in the Design & Development Life Cycle, and recommending strategies for most efficient and effective approvals of regulatory applications for the business • Lead RA for cross-functional teams providing regulatory guidance during all design control phases of a new product, a major change to a product, or a minor change to a product • Responsible for authoring, coordinating and preparation of document packages for regulatory submissions to the U.S., E.U., AUS/NZ, Canada, China, Japan, & Korea [510(k) Pre-market Notifications, Letter-to-Files, Product Reports/Supplements, U.S. Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for Philips’ manufacturing sites • Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDR (EU) 2017/745, CMDCAS, TGA, NMPA, PMDA, & Korea Medical Device Acts • Supporting compliance with EU MDR activities including updating Technical Files and associated design and development documentation • Lead on providing regulatory strategy and feedback to cross-functional teams and to represent regulatory as an active member of the program core teams

• Represent Regulatory Affairs on various cross-functional teams to provide guidance and support, including design verification, pre-clinical, and clinical studies focused on SaMD, SiMD, wearables, and combination products • Develop strategies and submissions for complex products to gain clearances and/or approvals for commercial distribution and clinical research in various geographies • Communicate, plan, and execute negotiations and meetings with regulatory agencies as the company representative, or in collaboration with development partners • Ensure that existing approvals and documentation are maintained by monitoring product changes to assure quality of design, development, manufacturing, and labeling • Lead proactive and continuous improvements for Regulatory Affairs and in support of the quality system. Maintain knowledge on changing worldwide regulations and standards that are relevant to Verily's business, including regulatory intelligence of the competitive industry space

• Oversee and direct all pre- and post-market regulatory activities for Fitbit’s current medical device in the U.S. and international markets • Lead on new product introduction teams throughout all phases of product development (Planning, Development, Verification & Validation, and Design Transfer) • Lead on creating regulatory strategy plans for product pipeline and business development • Lead and manage required content for successful domestic regulatory submissions, e.g. Q-submissions, de novo submissions • Successfully implemented FDA's Unique Device Identification (UDI) for Fitbit’s Aria 2 WiFi Smart Scale • Responsible for implementing the Global Regulatory Product Assessment process for ongoing management and maintenance of changes to Fitbit’s current and future medical device product(s) • Review and approve Engineering Change Requests, Design and Development deliverables, Regulatory Reporting Evaluations for FDA & Health Canada • Lead activities and coordinate communication for FDA’s Digital Health Software Precertification (Pre-Cert) Program. In 2017, the FDA selected Fitbit as one of the nine companies out of over 100 applicants to participate in the development of this pilot program.

- Responsible for U.S. regulatory activities for 23andMe’s products - Prepare, coordinate, and compile required documentation for successful domestic regulatory submissions, e.g. de novo, 510(k), Q-submissions. - Represent Regulatory Affairs on assigned project teams through all phases of product development (Planning, Development, Verification & Validation, and Design Transfer); communicate regulatory requirements and the impact of regulations to the core team to ensure compliance for the U.S. - Responsible for managing and maintaining FDA Establishment Registrations/Product Listings (FURLS) - Successfully implemented FDA's Unique Device Identification (UDI) for 23andMe’s product - Authoring and updating Regulatory Affair SOPs for 23andMe’s quality management system for compliance with 21 CFR 820 Quality System Regulation - Successfully project managed 23andMe’s internal audit response project for design control - Participated and led in two internal audits and one external audit: Software Design Control/Design History File Audit, Design Control Audit, and California Department of Public Health Medical Device Manufacturing License Audit