Submit and receive FDA clearance on approximately forty 510(k) applications annually. Have submitted hundreds of 513g, presubmission, SIR, EUA, pEUA, SBD, MDL, GUDID submissions. Developed successful regulatory strategies, submitted, and received approvals for 510(k), CBER 510(k), MAF, HUD, Q-submission, and Annual Reports (IDE/PMA). Assisted clients with Covid-19 emergency use authorizations including EUA and pEUA applications with FDA. Have arranged and attended many meetings or teleconference calls with FDA and average 16 annually. Assisted with development of the Licensale platform which manages simultaneous global regulatory applications. Successfully manage client product testing programs using partner labs including human factor/usability studies, biocompatibility studies, sterilization validations, distribution and packaging validations, microbial ingress, particulates, shelf life and end of life testing, electrical and EMC safety testing, software and cybersecurity validations, animal and bench performance testing, risk assessments, flammability, filtration, preconditioning-cleaning-disinfection validations for reprocessed equipment, and radiation safety reporting as part of client applications or AI responses. Established substantial equivalence discussions to predicate devices to support 510(k) applications, and 515i reclassifications. Performed regulatory strategy surveys, recalls and PMS, and other RA support functions. Redact documents and request documents via FOIA. Provide reports when needed on regulatory and/or quality topics for medical devices and combination products for US.

Developed successful regulatory strategies, submitted, and received approvals for employer 510(k), HUD, IDE, IND, USAN, PMA (pending), Q-submission, and Annual Reports (IDE). Provided RA support on multiple clinical investigations, several were conducted under IDE or IND approval. Managed R&D resources to complete regulatory applications and respond to AI requests on time. Established substantial equivalence discussions to predicate devices to support 510(k) applications. Performed regulatory strategy surveys, and other RA functions. Assisted with private reimbursement code development for product, applied for and received USAN name for a new molecular entity (NME) entered in the USP. Attended meetings with FDA, attended an appeal hearing. Completed a regulatory survey for national distribution of a pharmaceutical to comply with pedigree and state licensing requirements.

Developed successful regulatory strategies, submitted, and received approvals for employer 510(k). Managed R&D resources to complete regulatory applications and respond to AI requests on time. Established substantial equivalence discussions to predicate devices to support 510(k) applications. Performed regulatory strategy surveys, recalls and PMS, and other RA support functions. Managed QMS system to maintain ISO 13485, SOR/98-282, and Part 820 compliance. Ensured compliance to regulatory requirements and QMS regarding supplier controls, manufacturing, sterilization, promotion and labeling, complaint handling, and PMS requirements. Implemented investigations into complaints, represented employer during product liability lawsuits and defended employer in cases where suspect product was not the root cause of the event. Managed global customer complaint handling, Advisory Notices, Recalls. Maintained technical files, DMRs, DHFs, and design dossiers as state-of-the-art. Managed MDR reporting and vigilance while adhering to HIPAA. Managed CAPA and MRB programs, supported the (SOX) Sarbanes- Oxley Oversight Committee. Wrote and reviewed supplier agreements, distribution agreements, and direct sales agreements. Advised on corporate quality and regulatory compliance issues.

Developed successful regulatory strategies for clients as an OEM. Performed regulatory strategy surveys, assisted clients with recalls and PMS, and other RA support functions. Design History Files (DHF), Device Master Records (DMR), Quality System Record (QSR), and device History records (DHR). Managed QMS system to maintain ISO 13485, SOR/98-282, and Part 820 compliance. Ensured compliance to regulatory requirements and QMS regarding supplier controls, manufacturing, labeling, complaint handling, and discrepant material requirements. Implemented investigations into complaints, represented employer during product liability lawsuits and defended employer in cases where suspect product was not the root cause of the event. Managed global customer complaint handling, Advisory Notices, Recalls. Maintained technical files and design dossiers, FSCA, FSN, DMRs, DHFs. Managed MDR reporting and vigilance while adhering to HIPAA requirements. Managed CAPA and MRB programs, senior management review meetings, and internal audits including supplier audits.

Manufacturing engineer and ISO 9001 manager for products related to the gaming industry and the financial markets such as slot machine controllers, race books, and ticker displays. First company ever traded on the NY stock exchange.

QA Test Engineer on discrete clinical analyzers STAR and Dimension employed by Dupont and then Dade and Behring before Siemens takeover.

QA Engineer for automated material handling system (AMHS) as an employee of Daifuku at Intel fabs 9 and 11.

QA Test Engineer robotic automated accessories.

Worked for German version of NASA designing and testing electronic equipment for space exploration and aeronautical engineering.

Worked for International Consultants on Targeted Security using the El Al Israeli passenger profile interview process to ensure passenger safety on US carriers following Pan Am Lockerbie explosion while going to school.

Technical draftsman for Army projects, graduated from Fort Belvoir drafting school as an 81-Bravo, achieved rank of E-4.