Swati Seth Yadav
Program Manager, Quality Compliance at Masimo.
- Role
- Program Manager - Post-market Surveillance at Masimo
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Swati Seth Yadav
Highly organized and perseverant collaborative team-player with exceeding project management skills to multitask and prioritize workload to keep projects on time and on budget to completion. Skilled in translating complex scientific concepts into easily understood terms. Excellent writing and editing skills. Exceptional skills in training personnel in experimental techniques and procedures. Work well independently, as well as part of a team. Strong communication and interpersonal skills. Deadline oriented. PhD in microbiology with 4 years of medical device industry experience and over 10 years of infectious disease research experience. Expertise in medical and regulatory writing, clinical literature searches, risk/benefit analysis, editing, writing and communications, cell culture, molecular biology techniques, immunoassays, and flow cytometry.Specialties: Post-market Surveillance, Medical Writing, Regulatory Affairs and Compliance, Immunology, Microbiology, Infectious diseases, project management, Microscopy, Flow Cytometry
Experience
Program Manager - Post-market Surveillance
Mar 2025 — Present
PMS plans/reports and PSURs, risk/benefit evaluations of devices, and issue impact assessments in compliance with EU MDR, MDSAP and other competent authority requirements.
Education
Institute of Home Economics, University of Delhi
BSc, Microbiology
2003 — 2006
SPRINGDALES SCHOOL, INDIA
AISSCE, Science with Biology
2002 — 2003
Cranfield University
MSc, Clinical Research
2007 — 2009
UC Irvine
Certification, Regulatory Affairs and Compliance
2020 — 2021
Institute of Clinical Research (India)
Post Graduate Diploma in Pharmaceutical Management, Pharmaceutical Management
2006 — 2007
INTERNATIONAL CENTRE FOR GENETIC ENGINEERING AND BIOTECHNOLOGY
PhD, Biotechnology (Life Sciences)
2010 — 2013
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