• Assist clients with regard to obtaining marketing authorization for medical devices, drugs, drug-device combination products, IVDs, and dietary supplements in the US (regulatory strategies, listing, 510(k), PMA, IDE, NDA, BLA, etc.)• Perform mock-inspections regarding fulfillment of regulatory requirements for the US• Assisting clients in preparation for inspections / pre-approval inspections• Establish quality management systems according to ISO 13485, Council Directive 93/42/EEC, SOR/98-282 (Canadian Medical Device Regulation), 21 CFR Part 820, 21 CFR Part 210/211, and 21 CFR Part 4.• Implement compliant design control processes (including risk management and change management)• Training with regard to quality management and regulatory affairs for medical devices, drugs, and combination products

MedHF can provide Human Factors support throughout the entire product development process in accordance with Health Authority recognized standards. Our main services include:- Human Factors Research (Formative and Summative/ Validation studies)- Use related risk management- Instructions for use development- Expert regulatory support

• Evaluated evidence for regulatory action recommendations such as Warning Letters, Seizures, Injunctions etc… against non-complying manufacturers distributing unsafe medical devices;• Reviewed the manufacturing plan of high risk medical device original pre-market approval (PMA) submissions and supplements (i.e. 30-Day Notices) for approvability;• Collaborated with the Office of Device Evaluation (ODE) to ensure that 510(k) and PMA cleared device manufacturers continue to comply with medical device regulations after clearance and approval;• Supported the Center of Drug Evaluation and Research (CDER) and the Center of Biologics Evaluation and Research (CBER) with pharmaceutical/medicine related cases including pre-approval applications (i.e. NDA, IND, BLA etc…) of Drug/Biologic-Device Combination Products for compliance with Quality System Requirements (QSR, 21 CFR Part 820);• Processed medical device recalls (21 CFR 806 Correction and Removal) for classification based on public health risk and other relevant factors; and,• Interviewed and screened potential candidates, and train new hires. Combination Product Branch Lead• Represented CDRH in the development of combination product CGMP guidance documents and policies, in collaboration with other centers such as OCP, CDER, CBER and ORA;• Generated policies, Standard Operating Procedures (SOP), Work Instructions (WI) and training plans for Combination Product work activities;• Mentored staff on Combination Product review processes and review their work before clearance; and,• Reviewed pre-approval submissions of combination products with drug and biological medication products.

• Provided technical leadership and judgment in the evaluation of complex regulatory situations triggered from concerns with the safety and effectiveness of regulated products within the branch purview;• Supervised and oversaw branch activities including mentoring staff while managing, assigning and coordinating the tasks to achieve branch objectives;• Served as the focal point, advisor and signing authority for branch approvability reviews of medical device and combination product submissions; and,• Represented the branch in meetings with senior agency officials, program directors, and industry representatives.

• Assisted FDA District offices in controlling potentially violative devices upon entry into the U.S.,• Supported the Office of Compliance (OC), and the Office of In Vitro Diagnostics and Radiological Health (OIR) for regulatory decisions regarding imported devices; and,• Provided assistance to district offices, broker, importers and industry on device import requests.

• Reviewed imported regulated products to make risk based admissibility decisions, while ensuring compliance with FDA standards, and monitoring for counter terrorism indicators;• Inspected shipments and collected product samples for laboratory analysis;• Advised on enforcement policies, methods, and interpretation of import regulations; and• Established evidence of FD&C act violations to support regulatory actions.International Mail Facility Blitz Operations Investigator• Participated in three (3) International Mail Facility Blitz Operations in 2010 and 2011 which revealed the amount of counterfeit, violative and/or potentially dangerous products that enter the United States through International Mail;• Examined suspicious international mail packages/parcels for counterfeit products; and• Collaborated with other Federal Agencies such as:o Customs Border Protection (CBP), o Drug Enforcement Agency (DEA), o Federal Bureau of Investigations (FBI), o Immigration and Customs Enforcement (ICE), and o Office of Criminal Investigations (OCI).

Policy, Access and Use unit Essential Medicines and Health Products DepartmentHealth Systems and Innovation Cluster- Supported the development of the WHO Global Model Regulatory Framework for medical devices including IVDs (the Model), specifically co-authored and edited specific sections, and collated and integrated comments to the draft text;- Contributed to the desk review of Member States' regulatory system status performed for WHO's Global Atlas, a global reference on health technologies;- Reviewed the regulatory status of products submitted for listing in WHO's Compendium of Innovative Health Technologies for Low-resource Settings publication series;- Provided input on safety standards to support WHO's program for the prevention of deafness and hearing loss;- Assisted with updating WHO's medical device website to facilitate navigation specifically with the listing of all WHO publication related to medical devices;- Developed a fact sheet on medical device to be included in the WHO website and to be distributed as a brochure; and,- Compiled a list of health technology related terms from World Health Assemble (WHA) resolutions, WHO publications, WHO websites, and recognized international standards and guidelines.

(INTERNATIONAL EXPERIENCE - Ebola Outbreak Response)• Educated victims, their families and organized groups of Ebola dangers and prevention measures;• Interviewed potential Ebola cases for treatment and transfer needs to treatment centers;• Served as a CDC technical consultant for local Ebola response activities in collaboration with WHO, UNMEER, UNICEF, RedCross, Peace Corps, and the Guinean Ministry of Health;• Identified local surveillance weaknesses and recommended, developed and executed corrective projects to strengthen the response system;• Ensured organization, supervision and coordination of an effective contact tracing to contain Ebola cases; and,• Supported high quality data collection and documentation of outbreak and response accomplishments for the development of analytical and epidemiological studies.

• Performed validation activities for chemistry analyzers and hematology devices;• Evaluated products for conformance with acceptance criteria and specifications;• Compiled and examined data obtained during testing for 510(k) application; and• Troubleshot system problems and provided technical support for customers.

Design silicone scaffold for pancreatic islet cell transplantation in Diabetes treatmentAssess releasing and diffusion rate of steroids, Perform in-vitro and in-vivo tests and work with cell culture Use high technology testing equipments and molecular biology techniques, ELISA, MTTAnalyzed different drug concentrations weekly by means of ELISA testing.

June 2007 – Present • Listen, assist and help computer users with any computer inquiries • Maintain a quiet and orderly lab environment• Troubleshoot, repair and ensure machines readiness for function• Enforce lab policies and procedures