• Building a Regulatory Operations team (e.g., human resources, tools, and processes) to support:- Regulatory Information Management system (RIMs) i.e., global registration, applicable standards, and government regulation- International submissions (e.g., Eastern Europe, North Africa, Far-East, Middle-East, East Asia, South America, Australia)- Regulatory/Business Intelligence (Global)- Promotional material review (Medical, Regulatory, Legal – MRL)- Regulatory newsletter• Developing an Advanced Technology regulatory affairs team to:- Update SOPs to address recent developments in Artificial Intelligence and Machine Learning- Create regulatory pathways for SaMD, and electromechanical devices incorporating SiMD, - Provide ongoing support to the project teams,

Due to personal circumstances went on sabbatical in Israel

Led and coordinated a face to face pre-submission meeting with the FDA and successfully achieved the goals set for the meeting. Authored a Special 510(k) per FDA request (requested during meeting at CDRH) and a Technical File for hardware and software modificationsIdentified the need for and managed the Unique Device Identification (UDI) implementationParticipated in an FDA inspection

Developed regulatory strategies and regulatory requirement documents to support local and multinational projects supporting both hemodialysis and peritoneal dialysis devicesLead a high priority catch-up 510(k) to fulfil commitment to FDA and a Corrective Action Being Effected special 510(k)Provided leadership, guidance, and mentoring, to develop and manage direct reports

Provided quality guidance and support to CT platforms (regulated and no-regulated intermediates)Championed the Management of Change (MOC) Process throughout the Eastern Cluster CT Division.Lead and facilitated an effort to create a regulatory training program for quality team members. intending to support regulated platforms following the Systematic Approach to Training (SAT) modelConducted internal audits and lead supplier audits.

Developed the regulatory path for a proprietary solution to dramatically reduce radiation dose and exposure and participated in presentations to potential investors leading to a Series A financing of US$5.3 million.

Relocated from Medimop Medical Projects Israel, a West company, to establish regulatory affairs infrastructure to support newly-formed medical device division.Provided leadership and guidance in establishing systems for Regulatory Affairs department’s activities (regarding delivery systems - e.g., vial adapters, syringes, hypodermic safety needles, auto injectors) in harmony with the company’s strategic initiative and business goals.Prepared submissions to regulatory agencies worldwide FDA (CBER, CDER and CDRH), Health Canada, European community as well as countries in the Far East and South America.

Upgraded company’s quality infrastructure, positioning it for acquisition.Upgraded quality manual and quality system procedures, built metrology laboratory for quality control inspections (incoming, in-process and final release), created complaint database, developed methodology for investigating complaints and implementing procedures to reduce particulate levels in cleanrooms, and collaborated with critical suppliers to improve quality of supplied goods.

Turned company around by certifying it to EU MDD.Created organizational infrastructure enabling CE-Mark registration of company’s products. Processes and procedures defined and implemented covered all ISO 13485:2003, ISO 9001:2000 and QSR requirements.

Prepared and achieved J&J “Process Excellence” (Six-Sigma) award.Constructed organizational infrastructure (Leadership, Business Information Management and Analysis, Business Planning, Human Resource Development& Management, Business Processes, Customer/Market Focus) to excel in performance and achieve J&J Signature of Quality award.

Designed project quality plans and handled customer returns.Responsible for certification of employees, validation and approval of testing equipment, creation and implementation of quality plans for assigned projects and handling customer returns.