Responsible for providing Regulatory support to New Product Development (NPD) teams and Life Cycle Management teams. Accomplishments include:  Directly/indirectly supporting the Alaris Infusion Pump 510(K) project. Supported 510(k) submission deliverable timeliness and quality throughout all of the phases of the submission.  Represented RA on new product development project for software and medication management devices. Provided regulatory guidance and deliverables (i.e. regulatory assessments, ensure correct product classification, reviewing and providing regulatory input, etc.) as needed by the project teams. Provided all deliverables in accordance with project timelines.  Supported RA sustaining activities (i.e. performed regulatory assessments after changes were made to an already released product, GTIN determinations) as required. Major Achievement – 510(K) Clearance on the Alaris Infusion Pump which included a system of six (6) hardware with software devices and five (5) software devices.

Performed support activities related to US FDA and International device and plant listings, registrations, and import/export processes.Worked with cross functional teams to prepare, compile, and submit information necessary to support international registrations, renewals, tenders, health authority inquiries and deficiency letters. Provided support to inspections/audits by FDA, the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information.

With minimal supervision, provided Regulatory Support to project teams associated with product Life Cycle Management and the Issue Escalation process.Evaluated proposed product modifications for Regulatory impact on a world-wide basis.Performed Regulatory Assessments as needed.Coordinated with cross functional teams to prepare, compile, and submit documentation to support international registrations.

Performed support activities related to US FDA and International device and plant listings, registrations, and import/export processes.Guided a foreign contract manufacturer in performing their first Establishment Registration and Device Listing with the FDA.Participated in maintenance and review of technical files.Process owner and administrator for the Global Product Registration system.Coordinated with multiple team members and departments to establish the APDL (Approved Product Destination List) process.Served as Regulatory Affairs representative for New Product Development projects.Served as on-site project manager for the CE Mark Transfer Project (DJO, LLC to DJO France).Processed MDR’s / PRE’s within a timely fashion.Coordinated with cross departmental teams as needed in order to perform investigations and prepare responses to the European Authorized Representative MDR/Vigilance queries.

Performed support activities related to US FDA and International device and plant listings, registrations, and import/export processes.

Established, implemented, and maintained procedures and training program for compliance with FDA Quality Systems Regulations (QSR’s) and Current Good Manufacturing Practices (cGMP) at thecorporate headquarters in Newport Beach, California and the satellite facility in Costa Rica.Primary liaison between the company and auditors from the FDA and California Department of Public Health (CDPH).Reviewed and provided feedback on 510(K) submissions prior to submission.Assisted in assembly of the required information for technical files including preparation of all RiskManagement/Risk Analysis reports.Established complaint tracking system and processed complaint information. Ensured proper follow up on complaints and prepared monthly trending data.Established and maintained document control and CAPA systems. Initiated CAPA items as needed and ensured completion of CAPA within a timely fashion.Performed internal audits and prepared audit findings reports for the involved department management as well as Corporate Executive Management.Established QA/QC incoming raw materials inspection, quarantine/hold area, and non-conformingmaterial disposition procedures. Directed four employees from Research and Development inperforming the procedures.

Assisted the Studio department in developing training and marketing videos.

Updated the company’s master glossary and worked on improving the Education department’sprocedures.