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Project Consultant, Tx

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SUMMARY

  • Strong analyst, trouble - shooter wif international cross-functional experience in regulatory affairs, product manufacturing, quality assurance, supply chain and international trade compliance in teh 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 teh project as Leader of Regulatory Contractors team:
  • Assure dat teh “Medical Device” definition is correctly determined when created in teh new GE's database structure
  • Verify dat all teh attributes and documents attached to teh Medical Device entity are compliant wif teh FDA requirements and update when necessary
  • Prepare teh 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 teh LA BU VP and teh LA Sales Director, prepared and attended in Mexico pre-opening meetings of teh Mexican Distribution Center, including consequences of teh new RA/QA Regulations adopted by teh Mexican Agency COFEPRIS
  • Interpreted teh Spanish official text for teh Mexican facility and teh other imported products in Mexico
  • Anticipated teh future Brazilian Distribution Center wif personal Brazilian contacts for advise
  • Assisted teh QA Compliance Inspections performed by teh Brazilian Agency ANVISA in two Teleflex facilities in teh US (Boston & Asheboro). Prepared wif QA Managers teh following ones to be performed in Mexico and in teh 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 teh 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 teh US
  • Developed case studies for teh Import/Export Series training program of teh 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 teh 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 teh 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 this work to teh FDA.

Confidential

Business Consultant

Responsibilities:

  • For a veterinary project: surveyed teh 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 teh TÜV Rheinland.
  • Got Vitalitec products CE Marked: titanium clips (class III), vein strippers (class IIa)
  • Provided Vitalitec’s US Agent wif teh required documentation for teh 4x FDA 510(k) titanium clip filings
  • Managed teh 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 teh 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 teh first 3 ones (Argentina, Brazil, Chile)
  • Provided technical support to teh 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

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