Seasoned Regulatory Affairs Officer and leader with four years in developing effective processes and executing regulatory affairs initiatives for Medical Device industry. Partnered with GWU to improve processes and assist product development in meeting regulatory requirements, such as establishing registration, medical device listing Premarket Notification 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Quality System Regulations (QS regulation), Labeling, and Reporting. Maintained and followed up on records of regulatory information and submissions.
Rational cryptologic leader with four years of experience enhancing operations for organizations through information systems solutions. Proven track record of transforming specific business goals related to growth and efficiency improvements into new system designs. Knowledgeable innovator known for recommending new technologies to enhance existing systems and introduce new systems.
Results-driven Network Engineer with 10+ years of expertise deploying and maintaining LAN and WAN infrastructure. Dedicated technology professional with strong track record of accurately conducting system repairs and troubleshooting. Offering exemplary planning, project management and communication talents.
Motivated Biomedical Equipment Technician successful in providing biomedical equipment and device integration, inspection, maintenance and repairs.
Medical Device Statutes and FDA Integration Understanding
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