Experience

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  HCLTech Vietnam

  • Hanoi, Hanoi, Vietnam

  • Regulatory Affairs General Manager

    • Feb 2022 - Present
    • Hanoi, Hanoi, Vietnam

    -Managing Regulatory team in Vietnam to provide consulting service and final reviewing of the deliverables in Medical Device projects. -Regarding to the Medtronic HeartWare Ventricular Assist Device (HVAD) System Project, worked as Pseudo SME lead team to perform standard gap assessment and review the deliverables following the standards ISO 14708-1, ISO 14708-5, ISO 20417:2021, ISO 15223-1, EN 60601-1-6, EN 62366-1, and prepared the Device History File for the HeartWare ventricular Assist Device. And then carry out mitigation plan for the findings found out by gap assessment.-Regarding to COOK Medical EU project, Lead team as Subject Matter Expert for reviewing and remediation the Technical Documentation of the Catheters, IVF needles (Ovum Pick-up needles) Polypectomy Devices following the EU Medical Devices Regulation requirements. -Identification of global regulatory standards and requirements for said Medical devices.-Classification of Medical Devices based on USFDA, TPD, MDD, PAL and other National and Regional regulations.-Coordinate with external test labs for safety and compliance test.-Preparation and compilation of Technical Files for regulatory submission.-Effort and timeline estimation for regulatory activities for project planning.-Participate in review meetings to ensure Regulatory compliance in project deliverables.-Creating awareness to Design Engineers on Medical Device Regulations, through facilitation, conducting training programs.

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  B.Braun Vietnam Co., Ltd.

  • Hanoi, Hanoi, Vietnam

  • Manager of Quality Management

    • Nov 2018 - Feb 2022
    • Hanoi, Hanoi, Vietnam

    -For Medical Plant, Develop and manage the Quality Management System following the requirements of, ISO 13485 and J-QMS (Japanese QMS) to ensure that QMS is always adapted as the current applicable regulations.-For Pharma. Plant, Develop and manage the Quality Management System following the requirements of, ISO 9001, WHO GMP, GSP & GLP to ensure that QMS is always adapted as the current regulations.-Undertake general duties for managing change control system against a significant change of product or process. -Works with global R&D and global QM for managing the conversion of the Technical Documentation from MDD to MDR for the manufacturing product groups at THANH OAI Plant. -Undertake general administrative duties pertaining to implement quality activities largely involved in formulating Quality development plans, guidelines, policies and strategies as well.-Manage the Quality Management and the relevant function Department prepare the technical documents for converting the MDD’s medical devices following the EU’s MDR requirements. -Control the production processes risk management to be established and reviewed every year, then update it if required.-Handling the Change Control process to be made to the QMS’s processes will not impact to the medical devices, QMS & applicable regulatory requirements.-Manage the (re)-validation and (re)-qualification activities implemented for the critical production processes.-Manage new or developed product design transfer from R&D to the B.BRAUN VIETNAM exactly.-Direct the performance of company internal quality audit to ensure it is developed and executed following the IQA procedure effectively.-Govern a customer complaints handling system and take respond to the competent authorities for reportable case as Safety Officer for the company.-Provide effective training to new staff to ensure that all of basic quality control aspect and GMP are carried out effectively against demanding the company procedures.

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  TUV SUD Vietnam Co., Ltd.

  • Ho Chi Minh City, Vietnam

  • Lead Auditor for Medical Devices

    • Feb 2011 - Oct 2018
    • Ho Chi Minh City, Vietnam

    -Qualifications: -EU Notified Body Technology Auditor for Medical Device Directive (MDD) authorized by TUV SUD Product Services GmbH. -EN ISO 13485 - Lead Auditor authorized by TUV SUD Product Services GmbH. -EN ISO 9001 - QMS Lead Auditor authorized by TUV SUD Management Services GmbH.-ISO 15378 - QMS Lead Auditor authorized by TUV SUD South Asia Private Limited.-J-QMS Auditor authorized by TUV SÜD Japan Ltd.-Ethylene Oxide Sterilization Technology Auditor authorized by TUV SUD Product Services GmbH.-Perform EU MDD, ISO 13485, ISO 9001, ISO 15378 and J-GMP audit for the Medical Device industry under authorization of MEDEA Codes 12 (Chemicals, chemical products and fibres),13 (Pharmaceuticals production),14 (Rubber and plastic products production), 29 (Wholesale and retail trade, wholesale on a fee or contract basis), 35 (EO Sterilization and Moist heat sterilization). -Authorized by TUV SUD Product Sevices GmbH for auditing EU’s Medical Device Directive, QMS audit onsite and off-site file review audits upon procedures of TUV SUD Product Services GmbH following authorized code: MD 0101_2_1; MD 0101_2_2; MD 0101_2_3; MD 0102_1_1; MD 0102_2_2; MD 0102_2_3; MD 0102_2_5; MD 0102_2_6; MD 0104; MD 0105_1_1; MD 0105_2_1; MD 0107; MD 0108_1_1; MD 0108_1_2; MD 0108_1_3; MD 0109_1_1; MD 0203_1_1; MD 0203_1_3; MD 0204; MD 0302_1_1; MD 0303; MD 0402; MDS 7001; MDS 7005_1_1; MDS 7005_1_2; MDS 7006_1; MDS 7009.-Conducted audit for Medical Device company, manufacturing sterile syringe, infusion sets, transfusion sets, condoms, gloves, blood bag, Haemodialysis Concentrates, Surgical Drapes, Gowns and Masks, Blood Tubing Lines, Extension Tube of Endovascular Stent Graft System, Catheter Introducer, Angiographic Catheter, Catheter Guide Wire, Extracorporeal Blood Tubing Circuit for Heart-Lung Machine, Blood Tubing Circuit for Dialysis, Breathing Circuit, Tracheostomy Tube, Endotracheal Tube, Drainage Bag, Heat and Moisture Exchangers and Suction Catheters, Catheter.

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  TUV SUD Viet Nam

  • Hanoi

  • Lead Auditor

    • Feb 2011 - Feb 2011
    • Hanoi

    Auditor of ISO 9001 & ISO 13485