IVD Diagnostics

•Responsible for the preparation of domestic & international submissions; assuring compliance with foreign regulatory laws. Coordinated submissions through interaction with Research and Development, Manufacturing, Quality Control & Quality Assurance departments.•Communicated with regulatory authorities to expedite review and approval; met with external parties to resolve grievances and/or advance positions. Identified and resolved regulatory issues with relevant departments or offices. Compiling and submitting responses to FDA letters and annual reports for approved products.•Technical Files/Design Dossiers preparation and review of documents required for registration & submission of medical devices in Canada, China (SFDA), Japan, Singapore, Saudi Arabia, and Europe (CE Mark).•Resolve regulatory compliance issues occurring as a result of data discrepancies and manufacturing non-conformances. Support CAPA and quality investigations. Support other post marketing compliance activities; Field Actions, Recalls, MDRs, Vigilance and Complaints.•Drafted regulatory strategies for new and modified medical devices.•Monitored proposed legislation and regulations for possible impact and effect on the organization and its operations. Kept abreast of changes to European, US and Asia Pacific legislation ensuring timely communication of expected changes and requirements.•Planning, conducting and reporting of internal and supplier audit activities, as lead auditor, in accordance with the standards and maintenance of the Quality assurance system.•Review device labeling, advertisements/literature and Web site for accuracy, consistency and adherence to regulatory statutes.•Risk Management & Hazard Analysis for Medical Devices as per 14971:2007.•Prepare, review, and approve documentation: SOP’s, protocols, testing method procedures, MSDS, Certificates (C.O.C., C.O.A, and Declaration of Conformity), Technical Bulletins & FAQs and method validation protocols.

•Equipment, product & process validation;•Purchasing & QC/Acceptance of all chemicals (raw materials), laboratory supplies, and shipping & receiving supplies; •Sampling and Quality control on Finished product;•Maintain documentation for tracking and trending purposes;•Process Customer/Product Complaints; CAPAs & NCRs;•Development/preparation and review of Certificates of Analysis;•Author batch record and raw material specification protocols;•Calibration and maintenance of all laboratory equipment & certifications;•Author S.O.Ps, troubleshooting guides, and manuals for in-house procedures and equipment;•Maintain stability program & Validation of products to lengthen shelf-life;•Coordinate the supply of reference standards to the lab;•Perform internal audits, and external audits of vendors; •Assist RA under supervision of QA/RA manager to ensure company meets all regulatory requirements.

•Oversee all production and formulations in Bacteriology, Immunology, & Serology departments; •Worked with live cultures, blood & blood components; •Aseptic Culture Transfer and Isolation & Identification of microorganisms; •Sterile product handling procedure(s) & Sterile Filtration;•Maintain stability records on retention samples;•Monitor safe disposal of medical/biological waste as per OSHA, EPA & corporate guidelines;•Trained and directed new hires/technicians; •Performed routine environmental monitoring;•Performed microbiological water sampling: Total Plate Count, Coli Form, Endotoxin testing;•Competitive Benchmarking; •Developed and implemented large scale automated assembly system; supervised a crew in the operation, maintenance, and installation of machinery. Work directly with engineers and technical staff in configurations and upgrades;•Planned and implemented modifications to ensure safety, to improve operator ergonomics, and to increase machine productivity.FBI Clearance/Background Security Check to work with Bio-hazardous organisms.