9 years of increasingly responsible experience in Clinical Research and Regulatory Affairs in Medical Device and Pharmaceutical industry. with strong organizational, multitasking and communication skills. A strong desire to utilize, broaden and strengthen current skill set in Regulatory Affairs. I am self-motivated, analytical, and detail-oriented professional, successful in fast-paced, high pressured work environment. I have ability to learn independently and work effectively with peers. Goal-driven employee with the ability to prioritize and multitask to complete assignments within allotted time and resources. My regulatory background includes working knowledge of current FDA regulation and US regulatory submissions such as IND, CTA, 510(k), Technical File, Developing product labels and labeling, Review of literature searches, Quality System Regulation (21 CFR 820) and Quality management systems (ISO 13485:2003), CAPA, SOP development, Clinical Trials, Protocol Development, Auditing Clinical files, Case Report Forms, Audits, Risk Management, Post Market Computer proficiency with Microsoft Office products including Excel, Word, Access, Outlook, Microsoft Project, VISIO and other Microsoft programs.

Sr Regulatory Affairs Associate and Quality Specialist @ • Interfaced with FDA, notified body and international regulatory agencies on regulatory issues. • Prepared Technical File and STED for a new indication of USB Ultrasound Probe System. • Researched and provided regulatory strategy for product registration in Brazil. • Prepared application and obtained Certificate to Foreign Government (CFG) and Certificate of Free Sale (CFS). • Prepared Medical Device License Amendment submissions for Health Canada. • Conducted scientific literature search and reviewed scientific literature and updated clinical literature section of technical file. • Created, reviewed and approved product label and labeling in accordance with regulations. • Provided guidance to Own Brand Label (OBL) with their product registration. • Worked with distributor to obtained product registration in Philippines and Mexico. • Currently working with distributor in Turkey to obtain product registration in Turkey. • Prepared and managed documentation for annual registration and annual licenses. • Developed documentation for product registration activities; including Test reports, biocompatibility reports, and other documents needed for the submission. • Prepared sections of 510(k), provided feedback on 510(k), and assisted in response to FDA’s RTF letter for Interson’s OEM customers. • Prepared Software project file based on regulatory requirements. • Member of Risk Management Team. • Quality System Regulation and Quality Management Systems. • Lead attendee and escort of an audit such as, internal audit, CE Mark technical file audit and site audit. • Evaluated proposed changes to products (design control) and controlled documents. Recommended and implemented regulatory action plan based on changes. • Managed complaint handling. • Managed CAPA • Performed and presented statistical analysis of complaint and CAPA trending at management meeting. • Authored, reviewed, and updated Standard Operating Procedures (SOPs) and working instructions. From May 2014 to Present (1 year 5 months) PleasantonSenior Regulatory Affairs Associate @ • As a regulatory team member managed, coordinated and prepared submissions for CTAs and INDs such as: protocol amendments, information amendments, safety,annual reports • Prepared IND safety submission including completion of CIOMS and Form FDA 3500. • Worked closely with study staff at clinical sites to collect all study start-up regulatory documentation in accordance with ICH-GCP guidelines and sponsor specifications while adhering to strict timelines. • Managed Projects such as: o Managed sites’ regulatory document collection, review, and maintenance throughout the study life-cycle for approximately multi-center clinical studies carried out under different INDs. o Managed and reviewed clinical trial report; o As per sponsor requirements, reviewed and provided feedback on site specific Informed Consent Form (ICF) before sites submitted to IRB. o Reviewed and approved site and investigator documents pertaining to study for drug shipment authorization. • Maintained and contributed in design of document control database in MS Access for multi-center clinical studies carried out under multiple INDs. • Contributed in design of various study related reports. • Performed data entry, retrieval, QA and clean-up of data maintained in the document control databases. • Oversee maintenance of all clinical protocols and IRB approvals from approximately 30 different sponsored studies. • Authored, reviewed, and updated Standard Operating Procedures (SOPs); authored working instructions. • Prepared quarterly progress reports for the study’s sponsor summarizing the company’s performance. From 2012 to May 2014 (2 years) Mountain View, CARegulatory Affairs Associate II @ From 2008 to 2012 (4 years) Mountain View, CARegulatory Affairs Associate I @ From July 2006 to 2008 (2 years) Mountain View, CASr. Certified Pharmacy Technician @ From 2003 to 2006 (3 years) Raleigh-Durham, North Carolina AreaMicrobiology Laboratory Assistant @ From January 2003 to May 2003 (5 months) Raleigh-Durham, North Carolina AreaInorganic Chemistry Laboratory Assistant @ From January 2001 to May 2003 (2 years 5 months) Raleigh-Durham, North Carolina AreaTeaching Assistant, Biology Department @ From January 2001 to May 2003 (2 years 5 months) Raleigh-Durham, North Carolina Area

BS, cum laude, Molecular Biology and Minor in Chemistry @ Meredith College From 1999 to 2003 Master's degree, Clinical Research @ Campbell UniversityPost Graduate Course Work, Regulatory Affairs and Medical Device @ University of California, Santa Cruz Minoti (US) is skilled in: Medical Devices, CAPA, Post Market Surveillance, Document Control, Risk Management, FDA, Quality Assurance, Quality System, ISO 13485, Clinical Trials, Regulatory Affairs, Protocol, Regulatory Submissions, Sop, GCP, Drug Development, Clinical Development, CRO, Pharmaceutical Industry, eCTD, Clinical Research, Oncology