• Prepared and managed global regulatory submissions to support the use of device/biologic combination product in clinical studies and commercialization in US, EU, Latin America, Asia Pacific, and Africa• Represented RA in cross functional product development teams to provide input and recommendations for design and V&V activities to ensure regulatory submission requirements are understood and met• Represented RA in assessing device changes, nonconformities, audit findings, CAPA, and other quality system activities• Authored and maintained RA-related standard operating procedures and work instructions• Worked with and managed relationships with external partners/consultants/authorized representatives for regulatory strategy and submission activities

• Prepared and coordinated regulatory submissions for continuous glucose monitoring products in the US (PMA and 510(k)), EU (CE marking), and various countries in APAC and EMEA regions• Reviewed and approved change orders and supporting documentation for compliance to regulatory requirements • Represented RA on various cross functional teams to provide regulatory assessments and strategies• Contributed to the development of product/project plans and associated deliverables• Evaluated, selected, and oversaw interactions/collaborations with regulatory agents• Monitored and kept abreast of industry trends and global regulatory requirements, changes, and best practices• Performed regulatory operations functions including submission/approval tracking, metrics, budgeting, process standardization, and other continuous improvement projects

• Supported manufacturing and QA with effective nonconformance resolution (NCMRs, CAPAs, HHAs, audit findings, etc.)• Represented QA on Product Focused Team to sustain and improve commercial manufacturing, new product launch, and new facilities ramp up (including process validation and monitoring, risk management, failure investigations, etc.)• Reviewed, approved, coordinated, and drove disposition of material in MRB inventory• Performed and supported internal audits of manufacturing processes to ensure compliance to internal and external requirements• Provided front- and back-room support to facilitate audits by external parties• Compiled, analyzed, and reported quality system metrics for management review• Authored and reviewed quality system and manufacturing procedures and documents to support continuous improvement efforts• Supported software verification and validation activities for deployment of corporate electronic quality management system

• Supported all document control activities (e.g. processing change orders, assessing training impact, assuring compliance, issuing and maintaining manufacturing batch records, etc.)• Implemented changes to improve Agile system performance

• Maintained high content quality standards by ensuring user-generated content is clear, succinct, and engaging for millions of Quora users daily

• Produced and delivered high-quality and timely translations to clients (French to English)• 150+ completed jobs, mostly web/marketing content

• Conducted market research for new product launch and development (ambulatory ECG)• Identified key competitors and monitored industry trends for medical devices

• Assisted in conducting field studies for business faculty• Ran participant studies at Rady Behavioral Lab

• Served as the central liaison between the summer program at South Island School, the faculty, the administrative team, the 100+ students, and their parents• Handled all student-related issues, including class placement, logistics, attendance, mentoring, counseling, assessment, discipline, etc.

• Taught two courses to students from local secondary schools• Provided curriculum-related support to teachers within the English Department including lesson plan review and teacher observations

• Taught two courses to students from local secondary schools• Assisted in instruction for electives and in planning site-wide events