Shalini Sadda Email & Phone Number

California, United States

San Francisco Bay Area

San Francisco Bay Area

San Francisco, California

Santa Clara, Ca

• Responsible for wrting, reviewing, management and execution of global submissions in Canada/Latin America, Eastern Europe, Middle East and Africa and Asia Pacific regions• Active participation and leadership in various regulatory council meetings to provide strategic updates on product • Development of aggressive and detailed global regulatory strategies for product commercialization• Oversee processes involved with maintaining annual licenses, registrations and listings. Ensure compliance with product postmarketing approval requirements•Provide leadership by communicating and providing guidance towards achieving department objectives•Create immediate to long-range plans to carry out objectives established by top management•Interface with a variety of management levels on significant matters•Help recruit, develop and manage regulatory professionals

Santa Rosa, Ca

• Played a leadership role in review and approval of a wide variety of submissions, including design and manufacturing changes, labeling, promotional material, web page content, and advertisements for compliance with applicable regulations. Also, reviewed and approved test protocols to support regulatory submissions• As regulatory lead for next generation technology, provided input in quality system assessments, product development, and complaint handing system• Developed and implemented US and Europe regulatory strategies for Class III early phase trials. Successfully led several FDA and European regulatory meetings • Responsible for obtaining PMDA approval for implantable device. Key activities include completion of PMDA audits, responding to PMDA’s questions and leading preparation of the Panel Review Meeting• Responsible for global oversight of Class II and Class III devices for regulatory submission activities. Managed team to ensure international registrations, post-market reports and technical files are submitted on time• On-going leadership for “First in Human” early phase trials, which was initiated as a Senior RA specialist• During a six month rotation, supported a sister business unit to review complaints and implement several key field actions• Provided technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams• Provided project, department, and company guidance and training based on current and emerging regulatory affairs requirements

San Francisco Bay Area

• Successfully led and submitted the Shonin for a Class III implantable endovascular device• Served as a product lead for Class III device and managed all post-market compliance activities including PMA annual reports, post-market clinical study and annual clinical updates• Led cross-functional teams in the filing of multiple PMA Supplements for various Class III devices.• Develop world-wide regulatory strategy and submissions in support of manufacturing transfer of a medical device• Served as a regulatory lead for new product development including evaluating strategies for “First In Human” early phase trial and research clinical study to evaluate the device design• Mentored new hires to foster leadership skills and professional development• Integral member of an FDA and BSI on-site audits• Worked on a ten month marketing assignment for cross-functional experience and to gain a better understanding of the business

Santa Rosa, Ca

Worked on a short-term marketing assignment to gain cross-functional experience

San Francisco Bay Area

• Pivotal in submitting and obtaining PMA Approvals (US) for Class III implantable endovascular devices, which required effective collaboration with cross-functional teams• Prepared international submissions and PMA supplements for new products and design iterations (typically for Class III Implantable devices) as required to ensure timely approval for clinical studies and market release • Led the submission of compliance reports to FDA such as Annual Progress Reports, IDE close-out reports, Annual Reports, and Annual Clinical Update • Worked within Regulatory Affairs teams to improve Regulatory Affairs Business Procedures. Also, prepared regulatory training presentations to educate cross-functional teamsSuccessfully led and closed out corrective and preventive actions (CAPA) activities related to procedural non-compliance

Round Lake, Il

• Collected and summarized data on field activities for Baxter pumps and the competitive pumps• Ran identical testing in the laboratory comparing various pumps and assisted in the analysis of results• Prepared a report summarizing the test data and compared the Baxter and competitive pumps• Conducted research on electrical and mechanical components and materials• Assisted in the development of component qualification procedures• Designed and developed a report containing pertinent component information that can be assessed by Baxter

Masters, Biomedical Engineering/Medical Devices And Diagnostic Engineering

Bachelor Of Science, Electrical Engineering

High School, Sciences