Provide regulatory support for clients through design file review, 510k submission preparation, CE marking activities, international support, ad/promo review and product lifecycle management. http://www.kineticcompliance.com/

Quality and Regulatory team member supporting LifeWatch products & design changes through regulatory support, lifecycle management & quality oversight:Developed regulatory strategy documents for improved lifecycle/DHF management of new & on market products.Participated in design reviews for new product releases. Wrote letters to design history files documenting technical & regulatory rationale of design changes.Assisted in clinical research for product expansion, reviewed technical reports & specifications, built and received clearance for 510k submission for new pediatric indication.Led labeling projects associated with design / marketing changes and international expansion.Reported post market surveillance data in accordance with best practice.

Support PMA submissions for IVD nucleic acid testing of infectious diseases.

Plant Support and Life Cycle ManagementGlobal Product Owner-Evaluate manufacturing, procurement and compendial changes for regulatory impact. Prepare post approval submission packages for agency review.

Project Coordinator and SME managing procurement issues, vendors, documentation, technical reporting of CMC changes, analytical testing, chromatographic method transfers and validations across multiple sites for critical excipient, and API.Calibration Coordinator for laboratory personnel - Utilizing TrackWise quality management system to author and finalize records associated with exception reports, laboratory investigations and stability trends. Initiate CAPA.Authoring protocols and reports to transfer chemical testing to CRO or manufacturing site. Resolved quality concerns and strengthened relationship to move departmental objectives forward.Perform gap analyses of chromatographic test method validation protocols and reports. Documented appropriate method change history and mitigated potential FDA submission hurdles for biosimilar drug development programs.Container Closure Systems – Single primary reviewer collaborating with internal and external (vendor) sources to provide feedback and critique of analytical methods validations. Moved container closure safety assessment forward and helped establish protocol for stability monitoring of container related leachables.

Supported a broad base of scientific professionals across many technical disciplines (GC, HPLC, MS, ICP-AES, GFAAS, FT-IR, NMR, particle science, cellular assays) providing quality assurance and technical expertise for Bioscience, Cellular Therapies clinical studies, and Medical Packaging development studies. Reviewed laboratory data and wrote standard operating procedures in support of corporate research function.Prepared analytical reports upon conclusion of research and development protocols with an eye on details of objectives, experimental design, and an accurate presentation of complex results and conclusions.

Managed Annual Reporting to FDA for change control of batch records, labeling and specifications of drug product.Researched Bills of Materials, Mixing Procedures, and Product Control Specifications to identify changes in labeling, packaging, analytical testing and mixing procedures. Reviewed supporting protocols and test data for justifications.Prepared well-researched and thoughtful written submissions of said changes in an accurate & concise format.

Team member on various container closure development initiatives providing expertise in sample preparation, organic (GC/MS, TOC) and inorganic analysis (ICP-AES, GFAAS), extractables identification and instrument validation.Study Director-developed and implemented analytical methodologies for the screening, detection and identification of a suite of chemical compounds. Prepared technical protocols and reports to support product development, toxicological evaluations and regulatory submissions.Responsible for the maintenance and operation of gas chromatographs and bench top mass spectrometers.Instrumental team member on the resolution of a manufacturing issue in a packaged IV formulation. Received a Corporate Technical Award. Supported this product with the validation of a screening assay.