Sarah Dooley Email & Phone Number

Seattle, Wa, Us

Seattle, Washington, United States

Developed and implemented comprehensive global compliance strategy in a high-pressure environment. Resolved ambiguous safety concerns by establishing risk management parameters, adhering to regulatory protocols, and improving customer trust. Utilized machine learning, SaaS, and AI technology to achieve and maintain compliance. • Worked collaboratively with cross-functional teams to ensure proactive compliance with existing policies. • Designed and implemented global, federal, and state-level policies and audits. • Led process improvement initiatives, emphasizing scaling capability, efficiency, or cost reduction. • Implemented scalable tools designed to adhere to state and federal distribution and promotional limitations.• Earned trust from legal, business, engineering, operational, and other key stakeholders. • Developed a proactive monitoring process that alerted teams about drafted and enacted regional laws that could impact existing product listing and review criteria.

Seattle, Washington, United States

• Improved and clarified COVID product store verification criteria• Developed and established customer verification process for prescription and professional-use (Rx) COVID Test Kit purchasing • Partnered with Japan medical device local team to align on distribution, advertising restrictions, routing, and classification criteria for Class I-III medical devices • Created new SP initial onboarding content and resources to improve and simplify the onboarding experience• Improved Third Party (3P) Seller distribution control, license tracking, and messaging• Collaborated with business, tech, and legal stakeholders to gain alignment on licensing requirements and opportunities • Applied statistical analysis to Selling Partner (SP) initial onboarding rates to identify improvement opportunities• Point of contact for all customer, supplier, and facility medical device licenses• Integrated compliance requirements into business, tech, and customer-facing resources • Responsible for preparing State Board of Pharmacy application materials for all states and jurisdictions • Developed strong expertise in licensing requirements for Amazonian fulfillment options

Bothell, Wa

• Established new regulatory systems and procedures for consent decree export compliance• Managed export approval and global localization requirements • Integrated compliance requirements into business unit, quality, and regulatory procedures• Responsible for preparing product registration materials for Latin American countries • Prepared Regulatory Plans and Regulatory Strategy documents for consent decree-related projects• Developed strong expertise in post-market regulatory requirements • Consulted with critical cross-functional teams, including supply chain, marketing, legal, and international customer fulfillment centers to drive awareness for 801e1 export requirements

Seattle, Washington

Greater Seattle Area

Shanghai, China

Responsible for creating a macroeconomic study on China's healthcare reform in order to understand the changes and the future implications for Multinational healthcare companies in China Focused on clarifying and achieving cohesive understanding of timelines, risks, and assumptions for localizing in ChinaResponsible for writing a Quality Control procedure regarding adverse event reporting in ChinaDeveloped a strong understanding of Chinese governance, its goals as an emerging market and how these dynamics impact multinational business localization goalsResponsible for communicating key changes in China Food and Drug Administration (CFDA) regulations and health care reforms to functions such as regulatory affairs, quality control, quality manufacturing systems, and government affairs

Shanghai, China

Internship with two functions in Abbott China, including the Office of Ethics and Compliance, and Regulatory Affairs

Chengdu, Sichuan, China

Evaluated students’ English skills and prepared customized lessons. Taught students from ages 4-30 years old and prepared them for testing. Introduced new study methods, such as film and real life situations into the curriculum

San Jose, California, Usa

Coached teenagers and adults with cognitive challenges. Conducted life skills training, requiring leadership, motivational skills, behavioral observation, adaptability, and multiple case management

Master’S Degree, Biomedical Regulatory Affairs

Taking medicines and medical devices from concept to market

Bachelor’S Degree, Ba In Global Studies, Minor In Chinese Language

Activities and Societies: Studied abroad in Chengdu, China for two semesters at Sichuan University

Bachelor'S Degree, Chinese Culture And Language

Education record