Experience

Verily

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Technical Program Manager

  • May 2022 - Present

• Senior Regulatory Affairs Specialist

  • Jun 2021 - Jun 2022

• Regulatory Affairs Specialist

  • Jun 2019 - Jun 2021



Intuitive

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Engineer

  • Nov 2016 - May 2019

  Provided new product development and product change regulatory support for US, EU, and APAC: • Prepared traditional and special 510(k)s, CE Technical Files, Health Canada new license applications and amendments • Global license registrations for Korea, Taiwan, Japan • Reviewed and approved system verification and validation protocols and reports Provided new product development and product change regulatory support for US, EU, and APAC: • Prepared traditional and special 510(k)s, CE Technical Files, Health Canada new license applications and amendments • Global license registrations for Korea, Taiwan, Japan • Reviewed and approved system verification and validation protocols and reports



CR Bard

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• International Regulatory Affairs Associate

  • Nov 2014 - Nov 2016

  • Regulatory support for China and APAC • Created regulatory strategy, first-time registration submissions, change notifications, and renewals • Reviewed design documents to resolve quality- and material-related reviewer inquiries • Managed post-marketing activities for medical devices of all classes (e.g. change control assessments, labeling and promotional material review) • Effectively maintained cooperative communications and collaboration with all levels of employees, contractors, and vendors • Built and maintained trusted and productive relationships • Collaborated on cross-functional product development teams (in-depth interaction with marketing and engineering) Show less



Cornell University

• United States
• Higher Education
• 700 & Above Employee

• Research Assistant, Materials Science

  • May 2012 - May 2013

  • Investigated effects of substrate strain and lowered protein availability on adhesive forces of protein films • Utilized and developed data-acquiring methods for AFM spectroscopy and imaging • Created and optimized MATLAB codes to extract, analyze and map large amounts of force data • Investigated effects of substrate strain and lowered protein availability on adhesive forces of protein films • Utilized and developed data-acquiring methods for AFM spectroscopy and imaging • Created and optimized MATLAB codes to extract, analyze and map large amounts of force data



Mylan

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• R&D Intern

  • May 2011 - Aug 2011

  • Assisted chemists with procedures and analysis for testing a variety of drugs ready for market • Documented and filed analysis of laboratory data • Gained knowledge of regulatory pathways and company SOPs • Assisted chemists with procedures and analysis for testing a variety of drugs ready for market • Documented and filed analysis of laboratory data • Gained knowledge of regulatory pathways and company SOPs