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Click here or scroll down to respond to this candidate Candidate's Name , D.H.Sc., MPH, MBA
Street Address Rice RoadLithonia, Georgia Street Address
Cell PHONE NUMBER AVAILABLEE-mail: EMAIL AVAILABLE SUMMARY OF QUALIFICATIONS Health care professional with over 20 years experience in working in fast-paced clinical environments demanding strong organizational, technical, and interpersonal skills. Excellent communicator with strong analytical and problem-solving skills; excellent organization and time management skills; ability to work both independently and as part of a team. Managerial skills in team leadership, budget development, project management, and strategic planning. Experience in developing quality systems for performing laboratory testing that provide accurate and reliable patient test results within CLIA, CAP, OSHA and JACHO regulations. In depth understanding of risk management techniques, standards of health care risk management administration; federal, state and local laws; and methods for providing patient safety. In-depth knowledge of FDA and international regulatory requirements and medical device registrations, design control activities for medical devices, as well as experience with FDA and Notified Body inspections. Skilled in the planning and preparing regulatory submissions, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications.
Skilled in product life cycle regulations, including change controls, design controls, risk management, and verification and validation activities.EDUCATIONNova Southeastern University Fort Lauderdale, Florida
Doctor of Health Science August 2012Eastern Virginia Medical School Norfolk, Virginia
Masters of Public Health July 2005Troy State University Atlanta, Georgia
Masters of Business Administration December 2001
Norfolk State University Norfolk, Virginia
Bachelor of Science in Medical Technology May 1984PROFESSIONAL EXPERIENCESysmex America, Inc.
September 2021 to presentSenior Scientist Regulatory Affairs
Assess regulatory pathways for new product platforms and product modifications; develop regulatory strategies and tactical plans for submissions to FDA, Health Canada and other regulatory agencies as needed.
Write, review, and assemble high quality regulatory submissions to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
Provide strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies.
Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
Monitor scientific and clinical activity related to assigned product lines and projects in order to develop sound, clinically relevant content to support regulatory submissions and responses to regulatory inquiries.
Communicate with regulatory Agencies and attend Agency meetings as needed to assist the Regulatory Affairs Director.
Review and interpret existing and new external standards and regulatory requirements as they relate to Sysmex products and processes to ensure regulatory compliance US and Canadian Medical Device regulations and guidelines.
Conduct on-going surveillance to identify information on product clearances/approvals and rejections to develop best practices.
Keep current on FDA guidance and rulemaking to anticipate regulatory changes that may impact future products and submissions.
Develop and mentor junior Regulatory staff members.
Perform regulatory administrative activities and other duties as needed.
AvanosMarch 2019 to September 2021Regulatory Affairs Manager Medical Device Sustaining Projects Direct the development of Technical files and other documents (i.e., checklist) need to comply with the new
EU MDR regulations. Train staff in regulatory policies or procedures. Maintain current knowledge of relevant regulations, including proposed and final rules. Manage activities such as audits, regulatory agency inspections, or product recalls. Participate in the development or implementation of clinical trial protocols. Direct the preparation and authorization of 510k submissions and regulatory agency applications, reports, or correspondence. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Develop regulatory strategies and implementation plans for the preparation and submission of new products. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. Contribute to the development or implementation of business unit strategic and operating plans. Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats. Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.United States Food and Drug AdministrationNovember 2012 to March 2019Scientific Reviewer Coordinate the review of draft and final internal Standard (ISO) documents for In vitro diagnostic medical devices.
Provide guidance to industry for Point of Care Coagulation devices and CLIA-waived CBC analyzers. Responsible for review of regulatory submissions of hematology analyzers with cell image analyzers, automated urinalysis devices (with/without digital image analysis), coagulation screening and/or anticoagulation monitoring tests on plasma and/or whole blood using clotting, chromogenic, immunoturbidimetric, or chemiluminescent detection methods. Responsible for classifying all medical devices into Class I (General Controls), Class II (Performance Standards) or Class III (Pre-market Approval).
Provides leadership and guidance in scientific specialty area to other supporting level scientists within the Division. Guides and directs the review of scientific data provided in support of medical device actions.
Responsible for review of a variety of medical device actions (including but not limited to, premarket approval applications, product development protocols, applications for investigational device exemptions, premarket notification of intent to market a device, and establishment inspection reports) for medical devices. Make presentations to the medical and scientific experts who serve as panel members on the various FDA advisory committees which have the responsibility for the classification and premarket review of medical devices.
Develops, modifies, and evaluates existing guidelines and protocols concerning data required in device actions and data associated with testing of specific types of medical devices.
Participates as a member of a team of experts to develop general agency-wide guidelines applicable to the regulation medical devices. Presents reviews, conclusions, opinions, and recommendations to appropriate scientific review panels on PMAs, PDPs, petition for reclassification, etc.
Present presentations regarding key issues pertaining to the safety and effectiveness of the medical devices, outlines for approval or no approval of the device or the submission.
Provides scientific information and consultation to industry, academic and private laboratory scientist by providing information on agency guidelines and regulatory requirements concerning medical devices. Conducting research on the safety and effectiveness of materials used in the manufacture of medical devices.
Keep abreast of changes in the law and regulations affecting medical devices by examination of scientific and legislative literature, and by attending scientific meetings. Serves as an expert witness in scientific specialty field in court cases dealing with medical devices. Mentor for multiple new reviewers. Review of Establishment Inspection Report (EIR), FDA 483, Exhibits and Firm s Response. Consult for Companion Diagnostics, Biomarkers, and Drug Approvals and co-author of a poster for treatment of severe asthma patients with high eosinophil levels. Trained in FDA Quality System Regulation 21 CFR Part 820.Virginia Commonwealth University Health System
September 2009 to November 2012Medical Technologist Perform clinical testing consistently according to established standard operating procedures. Evaluate patient results before reporting by considering integrity, recognizing results that are abnormal or deviate from those expected.
Perform daily and monthly quality control. Prepare the lab for inspections.
Prepare reports for medical equipment that are defective and report any safety concerns or events concerning equipment. Perform laboratory equipment and test method validation. Maintain laboratory test/validation records in compliance with the regulatory requirements and ensure procedures/specifications are maintained. Write procedures for clinical trials testing. Prepare clinical trials specimens for processing. Communication with clinical trial sponsor and nursing staff, patient visit coordination, sampling, time management and product accountability. Clinical trial preparation involving the planning, assembling and instruction of the clinical trial team, development and evaluation of patient information. Reviewed applications and proposals for involvement of human subjects in research proposals.
Assisted in the performance of monitoring, auditing, analyzing, and reporting of clinical trials data.
Assisted in making sure reported clinical trial results were reliable and accurate, and that the rights, integrity, and confidentiality of clinical trial subjects were protected. Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens.Children's Healthcare of AtlantaNovember 2007 to September 2009Diagnostics Laboratory Team Leader
Responsible for the day to day operations of the laboratories of the Ambulatory Care Network consisting of five (5) ambulatory outpatient clinics, three (3) subspecialty clinics, two (2) Primary Care centers, two (2) outpatient surgery centers. Responsible for coaching and leading staff and ensuring customer satisfaction.
Evaluated the function of the department including scheduling and functioning of the technical staff. Overseeing the preventative maintenance programs for assigned equipment. Assisted the Manager in the budgeting and long-range planning process for the department, control inventory of department supplies, working within budgetary restrictions and coordinate purchasing/inventory control.
Assisted in interviewing and hiring of staff, conducted performance appraisals and made recommendations to the Manager regarding disciplinary matters; mediated individual personnel concerns and referred to the Manager any unresolved problems relating to staffing, scheduling, work methods, morale, procedures, safety, and other issues regarding the laboratory personnel.
Monitor and evaluate the quality and appropriateness of patient care and clinical performance of the assigned clinics. Conducted safety training concerning patient care and how to report events involving medical equipment that is not functioning properly or equipment not having a current inspection sticker. Removal of the equipment from service and the reporting of these safety events according to organizational policies. Review weekly recall medical device data to prevent defective equipment from being utilized by employees. Maintained laboratory test/validation records in compliance with the regulatory requirements and ensure procedures/specifications are maintained. Responsible for updating procedure manuals concerning WBC differential, erythrocyte sedimentation rate, coagulation screen and clotting factor assays on blood samples and chemical and microscopic analysis of urine in hematology section.Virginia Commonwealth University Health System
July 2006 to November 2007Medical Technologist
Performed clinical testing consistently according to established standard operating procedures.
Evaluated patient results before reporting by considering integrity, recognizing results that are abnormal or deviate from those expected.
Trained new employees and medical technology students. Performed daily and monthly quality control. Prepared the lab for inspections.
Sentara Virginia Beach General Hospital
November 2004 to July 2006Medical Technologist
Performed routine and state laboratory testing in each area of the lab. Responsible for instrument maintenance and troubleshooting.
Performed daily and monthly quality control. Prepared the lab for inspections.
Maintained laboratory test/validation records in compliance with the regulatory requirements and ensure procedures/specifications are maintained.
Portsmouth Naval Hospital
October 2003 to August 2004
Medical Technologist
Performed ABO-RH typing and antibody screening. Issued blood and blood products.
Performed safety functions according to the standards and safety requirements of the organization.Grady Health System
February 2001 to August 2003
Medical Technologist
Performed stat and routine testing in the Chemistry lab. Trained new employees. Instrument maintenance and protocols. Computed department workload on a daily basis.
Performed instrument troubleshooting during instrument malfunction. Performed monthly, weekly, and daily instrument maintenance. Worked with upper management to improve the laboratory testing efficiency.
St. Joseph Hospital Atlanta
June 1999 to February 2001
Medical Technologist
Performed stat testing for outpatient clinics, surgery and inpatient departments.
Prepared lab for State, JCAHO, OSHA, and CAP inspections. Responsible for monthly quality control report for Hematology instruments and instrument repair when quality control was out of range.
Responsible for updating QC ranges and quality control supplies for Hematology and Coagulation instruments within the Stat laboratory.Serological Lab
October 1998 to May 1999
Medical Technologist
Performed state testing for hepatitis and HIV. Prepared reagents and controls.
Performed instrument maintenance and troubleshooting. Participated in FDA, and German inspections.McGuire VA Hospital
February 1998 to September 1998
Medical Technologist
Responsible for performing a wide range of emergency procedures in hematology, chemistry, urinalysis, microbiology, and immunohematology. Identified unusual results or discrepancies which may cause erroneous results.
Took appropriate action to make corrections and select an alternative procedure, if there is a problem with the instrument, or test results.
Evaluated the validity of data in relation to the quality control guidelines, test system, and assay procedures. May perform other tests to confirm or extend abnormal patient data.
Prepared reagents, assembles equipment, verifies correct instrument operation; standardizes, performs, and calculates results for a variety of complex tests such as Discrete analysis, Microscopic cell counts, Flow analysis, Toxicology, Therapeutic drug monitoring, and Coagulation testing.
Reported to doctors or nursing staff any lab results that are abnormal or inconsistent with hospital normal ranges. Performed genotype studies to determine ABO and RH Systems, the nature and serologic characteristics of their antibodies.
Identified common and rare subgroups of A and B (inherited and acquired) and the role of each in transfusion reactions.
Laboratory Corporation of America
July 1993 to October 1997
Group Lead
Assigned and reviewed work of technical department employees on a daily basis based on assessment of department needs. This included scheduling and prioritizing work, scheduling work hours to ensure adequate coverage and handling of specific projects.
Trained new employees and monitored performance of all employees in work group.
Performed routine and stat testing on patient samples according to established testing procedures. Operated routine to complex manual and/or automated equipment in order to perform assigned duties.
Acted as a liaison with other departments and customers on technical inquiries and test results.
Participated in validating and/or writing test procedures. Adapted methodologies and worked on new methods of performing test.
Responsible for preparing reagents and controls. Ordered reagents and controls as needed.
Performed maintenance and troubleshooting required for instrument operation. Implemented a new quality control system for evaluating urine specimens.Johns Hopkins Hospital
July 1990 to July 1993
Medical Technologist
Performed both routine and specialized clinical laboratory tests in assigned laboratory section.
Prepared and determined suitability of reagents, and controls.
Interpreted patient results with respect to quality control. Reviewed patient results for accuracy and notified physicians of panic results and any problems concerning specimens.
Maintained and troubleshoot equipment as needed. Assumed Lead Technologist responsibilities by training new employees or supervising medical technicians and training hospital residents in lab testing.
Implemented a new procedure for troubleshooting blood-gas analyzers.
Richmond Health Care Group
October 1989 to July 1990
Laboratory Supervisor
Developed and implemented quality control procedures. Created a procedure manual for all laboratory procedures. Established a yearly budget for laboratory.
Performed instrument maintenance and troubleshooting. Purchased all laboratory instruments and supplies.
Set up position descriptions and standards of performance for all laboratory positions.
Responsible for the hiring and training of all new employees.
Southside Regional Medical Center
March 1986 to October 1989
Assistant Supervisor/Evening Shift
Performed stat and routine laboratory testing in each area of the laboratory assigned. Supervised Medical Laboratory Technologists and Phlebotomists in the absence of the supervisor. Prepared reagents, controls, and calibrators.
Performed, checked, and documented quality control values for all tests and procedures; initiated corrective action when values did not fall within the established limits. Performed instrument maintenance and troubleshooting when needed.
Communicated with nurses, physicians, supervisors and co-workers to report diagnostic data, and resolve any incidents that compromised patient care.
Trained new employees in laboratory policies and procedures.
Recognized unusual results and take appropriate action to account for these results. Set-up microbiology specimens for isolation and identification of clinically significant organisms. Also performed and evaluated gram-stain smears.
Performed periodic safety inspections and ensured that laboratory personnel adhered to all practices and regulations related to workplace safety. Collected data and performed analysis of workplace exposures to track trends and ensure proper reporting of events to regulatory agencies.
PUBLICATION DEVELOPMENT
Responsible for updating Guidance for the Review Criteria for Assessment of Qualitative Fecal Occult Blood Member of Reagent Replacement guidance document working group.PRESENTATIONS AND PUBLIC MEETING
Gave a presentation at the World Endoscopy Meeting on Fecal Occult Blood (FOB) review by FDA May 15, 2015. National Colorectal Cancer Roundtable (NCCRT) established collaboration with stakeholders the American Cancer Society and Fight Colorectal Cancer Organization to articulate the rationale for FDA policies concerning Fecal Occult Blood testing and identify improvements for the regulation of FOB devices. American Association for Clinical Chemistry (AACC). Presented a poster on coagulation at Point of Care Conference. Chairperson for the Capacity Assistance for Higher-Impact HIV Prevention PS14-1403 Program for the Centers for Disease Control; December 2013.PROFESSIONAL AFFILIATIONSRegulatory Affairs Professional Society (RAPS)American Society for Clinical Pathology (ASCP)HONORS AND AWARDS DIHD Recognition Award, Excellence in Team Work Standardization Review Requirements for Hematology Devices, FDA Letter of Appreciation, Job Performance, VCU Health System
Letter of Appreciation, Job Performance, Grady Health Care System Caught by an Angel, Job Performance, St. Joseph Hospital Performance Award, Job Performance, Laboratory Corporation of America Certificate of Appreciation, Children s Hospital Certificate of Recognition for Job Performance, Laboratory Corporation of AmericaREFERENCES AVAILABLE UPON REQUEST |
