Project Consultant, Tx
SUMMARY
- Strong analyst, trouble - shooter wif international cross-functional experience in regulatory affairs, product manufacturing, quality assurance, supply chain and international trade compliance in the medical device industry; a proven track record in product development and marketing support throughout Latin America.
- Developed Quality Assurance Systems from ground
- Edited / Translated Quality Manuals, SOPs and Working Instructions. Designed forms for records
- Organized and later performed internal audits
- Performed Sterilization Validations (EO and radiation)
- Performed risk analysis and management (ISO 14971)
- Organized CAPA management
- Liaised wif Notified Bodies (ISO Auditing)
- Developed / negotiated sub-contracting manufacturing (Mexico, Brazil)
- Surveyed design changes, implemented specific quality control
- Performed Supplier audits
PROFESSIONAL EXPERIENCE
Confidential
PROJECT CONSULTANT
Responsibilities:
- Started the project as Leader of Regulatory Contractors team:
- Assure that the “Medical Device” definition is correctly determined when created in the new GE's database structure
- Verify that all the attributes and documents attached to the Medical Device entity are compliant wif the FDA requirements and update when necessary
- Prepare the same concept for other countries/regions where a similar requirement are or will be in place (e.g. Europe, China, Japan)
Confidential
REGULATORY AFFAIRS CONSULTANT
Responsibilities:
- Complementary 510(k) for families of lead and trunk cables
- IEC/UL 60601 Compliance - Pending review
- Performed translations, technical research, compliance analysis, manufacturing changes recommendations (continuation)
- Regulatory surveillance, FDA US Agent
Confidential
SENIOR REGULATORY AFFAIRS SPECIALIST,
Responsibilities:
- In conjunction wif the LA BU VP and the LA Sales Director, prepared and attended in Mexico pre-opening meetings of the Mexican Distribution Center, including consequences of the new RA/QA Regulations adopted by the Mexican Agency COFEPRIS
- Interpreted the Spanish official text for the Mexican facility and the other imported products in Mexico
- Anticipated the future Brazilian Distribution Center wif personal Brazilian contacts for advise
- Assisted the QA Compliance Inspections performed by the Brazilian Agency ANVISA in two Teleflex facilities in the US (Boston & Asheboro). Prepared wif QA Managers the following ones to be performed in Mexico and in the Czech Republic
- Reviewed Promotional Material (brochures), Instruction for Use and Labels
Confidential
INTERNATIONAL REGULATORY AFFAIRS SPECIALIST
Responsibilities:
- Edited Design Dossier for Europe / CE Marking for bio Implants from animal tissue (class III devices)
- Presented international regulatory strategy for new devices and / or re-designed / modified existing devices
- Challenged development teams to issue in time the required technical documentation justifying regulatory claims
Confidential, TX
QUALITY / RISK ASSESSMENT ENGINEER
Responsibilities:
- Performed complaint handling and risk assessment compliance: CAPA closing / follow-up requirements
- For risk management remediation (project): re-evaluated hazard analysis, FMECA’s (ISO 14971) for most of all devices from post market information
Confidential
INTERN / COUNSELING TEAM
Responsibilities:
- Bureau of Industry and Security (BIS) Conference: organization and assistance staff member; registration and documentation preparation; daily assistance
- Global Market Series: Imports and Exports; NAFTA/FTA conferences
- Counseling projects for Small Businesses: provided assistance to several local small businesses in terms of market research, counseling, importation regulation guidance for products as diverse as iron alloy castings, cosmetics, fruits and vegetables produced and/or sourced in or out countries wif FTA agreements wif the US
- Developed case studies for the Import/Export Series training program of the ISBDC
- International Trade Certification: BIS: Export Compliance; Encryption Regulations – Importation Regulations – DoC: Exportation – NAFTA/FTA’s Specific Regulations
Confidential
REGULATORY AFFAIRS CONSULTANT
Responsibilities:
- Consulting Contract: provided on-going technical support for FDA registration in the USA – ECG Electrodes and cabling (510k Submission through TÜV Rheinland – Cleared in July 2010).
- IEC/UL 60601 Compliance – ISO 14971 Risk Analysis review
- Performed translations, technical research, compliance analysis, manufacturing changes recommendations
- Maintained Regulatory surveillance, in addition to be their FDA US Agent
- Liaised wif CE Notified Bodies (TÜV, G-Med) and FDA
Confidential
REGULATORY AFFAIRS/QUALITY ASSURANCE CONSULTANT
Responsibilities:
- Performed regulatory assistance for current Vitalitec Group QA Manager: regulatory vigilance / FDA monitoring
- Improved risk analysis (FMCA) and CAPA management compliance as a result from FDA regulations monitoring
- Prepared, translated and assembled documents required for device registration in Far-East (China, Japan, Korea, Hong-Kong, Taiwan and Singapore)
- Filed product registration for Latin America (Brazil, Argentina, Mexico, Peru, Venezuela, Uruguay and, Colombia)
- Studied the Canadian regulations (CMDCAS) and compliance requirements, leading later to manufacturer and product registration
- Developed / negotiated sub contracting manufacturing (Mexico - Vitalmex, Brazil - Edlo)
- Performed annual supplier audits for Vitalitec (wif cross-business partner Edlo)
- Vitalitec France asked me to perform again their US/FDA Regulatory vigilance from 05/2010 to 07/2012
Confidential, USA
Regulatory Affairs and Marketing Consultant
Responsibilities:
- Performed market analysis: cardiology devices: radioactive balloon, pacemaker leads, vena cava filter
- Revised and made compliant to FDA’s “Part 11”, software validation and performance of an original Electronic Patient Diary
- Presented dis work to the FDA.
Confidential
Business Consultant
Responsibilities:
- For a veterinary project: surveyed the feasibility of an ESB / animal protein detection analysis system (based on nanotechnology); its legal and economic impact; studied and verified patents of competitive systems.
Confidential
REGULATORY MANAGER
Responsibilities:
- Set up from scratch Vitalitec’s complete Quality Assurance System under QSR / ISO standards, certified in 18 months ISO 13485 by the TÜV Rheinland.
- Got Vitalitec products CE Marked: titanium clips (class III), vein strippers (class IIa)
- Provided Vitalitec’s US Agent wif the required documentation for the 4x FDA 510(k) titanium clip filings
- Managed the OEM relation wif Aesculap/BBraun (Clip in special cartridges for reloadable appliers)
Confidential
INTERNATIONAL CUSTOMER SERVICE
Responsibilities:
- Direct supervision: 3 to 5
- Exports assistance: Europe, “Exotics” (India, Pakistan, Taiwan, Japan)
- Managed the OEM relation wif Aesculap/BBraun (Clip in special cartridges for re-loadable appliers)
- European and international meetings presentation
- Prospected Latin America, for potential and first Distributors; appointed the first 3 ones (Argentina, Brazil, Chile)
- Provided technical support to the domestic (French) sales reps network (9 reps)
- Wif Polymed, initial International Distributor of Vitalitec: COFACE Program (Governmental Financial Assistance for Exportation - equivalent to ExImBank Assistance for SB) filing and granted