Highly dedicated professional with 9 years of experience in the medical device industry specializing in Quality Systems and Regulatory compliance for Class II IVD. Solid experience working with cross functional teams in all phases of the product life cycle. Goal oriented team player.
Microsoft Windows, Microsoft Office (Word, Excel, Power Point, Access, Outlook), Microsoft Visio, Microsoft Project, Adobe Acrobat Professional, Proquis, Maximo, Cimis.
International Project Specialist06/2012 to 06/2015Trividia Health Nipro Diagnostics, IncFort Lauderdale, Florida
Responsible for LATAM market, ASIA and Middle East regions.
Built knowledge base for each client's business, international region and objectives.
Define project scope, goals and deliverables that support business goals.
Sets and manage international sister offices expectations.
Develop full-scale project plans and associated communications documents.
Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion.
Liaison between internal departments and international sister offices: Operations, Customer Service, Customer Care, Regulatory Department.
Set and continually managed project expectations with team members and other stakeholders.
Identified and resolved issues and conflicts within the project team and internal departments.
Identified and managed project dependencies and critical path.
Continually seek opportunities to increase customer satisfaction and deepen international offices relationships.
Conducted project post mortems and created recommendations report in order to identify successful and unsuccessful project elements.
Developed best practices and tools for project execution and management.
Regulatory Affairs Analyst08/2010 to 01/2012Trividia Health Nipro Diagnostics, IncFort Lauderdale, Florida
Maintained external documents and applicable industry standards and guidance such as ISO, IEC, CLSI and FDA.
Performed gap analysis and prepared reports for management review.
Responsible for conducting internal audits to maintain compliance to the company Quality System as well as to FDA 21 CFR Part 820, ISO EN 13485, ISO 14971, CMDCAS Health Canada, and European IVD Directive standard requirements.
Reviewed technical documents and labeling in support of regulatory product submissions.
Reviewed product Instructions For Use (IFU) and labeling per current regulatory requirements.
Assisted International RA Manager/Global RA Manager/Director prepared 510(k) submissions and maintained US and international product dossiers.
Coordinated language translation activities with professional translator, graphics department, and customer.
Regulatory Affairs/Quality Assurance Analyst I07/2006 to 01/2010Trividia Health Nipro Diagnostics, Inc. and Home Diagnostics, IncFort Lauderdale, Florida
Assisted in the preparation and review of 510(k) submissions and technical file to FDA agency.
Conducted searches/updates for domestic and International guidelines and Standards.
Responsible for conducting internal audits to maintain an effective quality system process and product as well as assure compliance to FDA CFR21 Part 820, ISO EN 13485:2003, CMDCAS Health Canada and European IVD Directive standard requirements.
Ensured US and International regulatory compliance of all packaging labeling and literature as well as promotional materials.
Proofreads, enters, approves and updates labeling/literature documentation in electronic documentation system.
Generated/revised quality system procedures and product instructions for use/labeling per current regulatory requirements.
Responsible for issuing batch records upon request and assigning associated lot numbers.
Responsible for proofreading of all finished batch records in accordance with CGMP.
Track and report batch record errors.
Assist with internal Quality System auditing and regulatory and quality assurance projects as needed.
Quality Control Auditor03/2003 to 02/2005DynCorp InternationalManta, Ecuador
Reported on Regulatory issues that impact contract compliance, Statement of Work, U.S.A.
Air Force manuals (AFMANS), Food Code, OSHA and other applicable regulations to Military Service Areas.
Utilized the Quality Control Management Systems to improve contract performance and effectiveness within budget requirements.
Audited and inspected military Foreign Outpost Location (FOL) areas including lodging, dining facilities and administrative offices to ensure compliance with required standards.
Issued Corrective Action and Preventive Action (CAPA) Plans with follow-ups to ensure compliance was met and monitored accordingly.
Participated in improving Government rating that eliminated Special Interest Item (SII) taking it from a commendable to an outstanding rating.
DynCorp International- FOL Manta Safety Award 4th Quarter 2004
Education and Training
Masters of Business Administration (MBA): International Business2013Keiser UniversityFort Lauderdale, Florida, USAInternational Business
Bachelor of Science Degree: Business Management2005Universidad T�cnica Particular de LojaManta, Manabi, EcuadorBusiness Management
Activities and Honors
Quality Audits for continuous improvement - United States Air Force 2003
Quality Audit Report for Improvement - United States Air Force 2003
Internal Auditor Certification - DYNCORP International 2003
Administrative, Adobe Acrobat,auditing, Customer Satisfaction, Customer Service, Customer Care, documentation, Government, graphics, internal audits, ISO, regulatory compliance, Access, Excel, Microsoft Office, Outlook, Power Point, Microsoft Project, Microsoft Visio, Microsoft Windows, Word, Packaging, Project plans, promotional materials, proofreading, Quality, quality assurance, Quality Control, translation, translator