marysa lyew
About
To apply my understanding of the regulations and standards toward achieving quick and effective approval, support the business in regulatory and compliance needs, and assist in formulating and maintaining regulatory strategies to bring the highest quality of products to market.
united states
san jose
medical devices
recalls, invasive species, corrective actions, adobe contribute, vendors, community, undergraduate, change control, agile methodologies, regulatory affairs, change orders, dec alpha, failure, work ethic, pma, plots, cross functional team leadership, complaints, regulatory compliance, management, design, evening, delta, educational workshops, resolve, committees, powerpoint, 21 cfr, human resources, detail oriented, grass gis, cell, layout, fundraising, reports, inventory, risk analysis, microsoft excel, property, prescription, customer service, regulatory submissions, conferences, engineering change, quality control, research, system monitoring, communication training, field service, investigation, microsoft, capa, analysis, written, community service, omega, pharmacists, complaint management, web design, hipaa, universities, fmea, advertising, quality assurance, restoration, summaries, workshops, quality system, degrees, vigilance, donations, emblem, ide, san jose, pharmacy, endoscopy, stocking, mc, iso 13485, responsibility, packaging, regulations, international, biology, mdr, reviews, process improvement, visio, medical devices, oracle, microsoft word, manufacturing, internal controls, budgets, fda, evaluation, coordinated
Experience
clerk
kaiser pharmacy
* Quality control on prescription packaging for all local Kaiser pharmacies and mail-order patients in the entire Northern California * Assisting pharmacists in stocking the medication * Report on inventory usage * Inspect technical medical devices for malfunction * Collegiate Activities:
quality systems complaint specialist
optovue
complaint specialist
fresenius medical care
senior regulatory affairs associate
hansen medical
regulatory affairs specialist
abbott
* IDE Experience with bioabsorbable vascular stent technology that is a combination class III medical device. * biocompatibilty * Manufacturing changes * PMA Experience with drug combination class III cardiovascular medical devices * Handled submissions for DES clinical trials: annual progress reports, 6mo investigator lists, UADEs, trial closure, FDA questions * Provided manufacturing support for IDE products * Assisted with MedCert and DEKRA onsite audits, IBs, and Competent Authority requests * CAPA Experience * Owned RA process related CAPAs * Developed and implementing process improvements for the regulatory department to increase efficiency and promote consistency
assoc regulatory compliance analyst
stryker
* Complaint Handling * Trending and gap analysis for post market products * CAPAs * Recalls and Field Actions * MDR and MDV reporting * Nonconformance monitoring board member * Quality investigation review and approval * Operations and understanding of material handling
Education
university of the pacific
biology
Activities and Societies: Alpha Phi Omega
marysa lyew's Contact Information
Phone
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