PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regulatory Affairs Certification (RAC). Certified Lead Auditor for ISO 13485. Certified Six Sigma Yellow Belt. Experience working with multi-disciplinary teams. Proven organization and time management skills with ability to multi-task under stress. Exposure to national & international regulatory standards such as GMPs, ISO 13485, ISO 9001, QSRs, 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185, MDD 93/42/EEC, Class III products, PMA Supplements, and Clinical Evaluation, among others. Ability to work well under pressure and handle multiple projects and meet multiple deadlines, while managing priorities accordingly. Prior team building/management and supervisory experience. 2 master's degrees (Health Administration & Public Administration). Fluent in Spanish and Portuguese. Medical Device Product Exposure Areas: Ophthalmic Ultrasound devices Ultrasonic Hard Tissue Cutting devices Absorbable and Non-Absorbable Sutures Aortic and Thoracic Stent-graft devices Dental Implants (including restorative abutments, surgical tools, and regenerative bone) Vascular Access: PICC Catheters, Dialysis Catheters, Feeding Tubes, vascular ultrasound, Implantable Port Catheters, infusion needle sets

Highlights:

• Management
• Regulatory Affairs
• Assessments
• Audit
• Budgeting
• ISO
• Microsoft Office
• Quality
• Quality Assurance
• Quality Management
• oncology
• protocol
• 13485
• FDA
• 483
• Warning Letter
• Portuguese
• Spanish
• ANVISA
• Lead Auditor
• Quality Systems
• Quality Audit
• Medical Device