蘇耿民 Andy Su

Senior Engineer/Project Manager at Flat Medical, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Taipei, Taipei City, Taiwan, TW
Languages
  • Chinese Native or bilingual proficiency
  • English Full professional proficiency
  • Taiwanese Native or bilingual proficiency
Skills

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Credentials

  • ISO13485:2016 Internal Auditor
    DNV GL
    Dec, 2016
    - Sep, 2024
  • TOEIC
    -

Experience

  • Flat Medical, Inc.
    • Taiwan
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Engineer/Project Manager
      • Feb 2020 - Present

      1. MDR build up 2. Winning the 2021 Taiwan BIO Awards- Innovation Awards 3. ISO13485/GMP renewal 4. Medical device certification application (EU/ USA/TW) 5. Solving technical problems/ writing DHF 6 .Responsible for the MENA region. 1. MDR build up 2. Winning the 2021 Taiwan BIO Awards- Innovation Awards 3. ISO13485/GMP renewal 4. Medical device certification application (EU/ USA/TW) 5. Solving technical problems/ writing DHF 6 .Responsible for the MENA region.

  • SOHO
    • Spain
    • Movies and Sound Recording
    • 1 - 100 Employee
    • Consultant(medical device registration/ GMP certification)
      • Aug 2017 - Present

      1. ISO 13485/GMP consultant 2. MDD consultant 3. FDA consultant 4. IEC60601/ISO10993... consultant 1. ISO 13485/GMP consultant 2. MDD consultant 3. FDA consultant 4. IEC60601/ISO10993... consultant

  • Elsevier
    • Netherlands
    • IT Services and IT Consulting
    • 700 & Above Employee
    • Translator
      • Mar 2016 - Present

      作品: 1. Murry-Medical MIicrobiology 2. Abbas-Immunogy 5E 3. Atlas of Clinical Sleep Medicine 4. Dysphagia:Clinical Management in Adults and Children 2/E 作品: 1. Murry-Medical MIicrobiology 2. Abbas-Immunogy 5E 3. Atlas of Clinical Sleep Medicine 4. Dysphagia:Clinical Management in Adults and Children 2/E

  • Industrial Technology Research Institute (ITRI)(工業技術研究院, 工研院)
    • Taiwan
    • Research Services
    • 700 & Above Employee
    • Regulatory Affairs Specialist
      • Jul 2018 - Jul 2019

      - GMP application consultant - FDA submission/registration consultant - Taiwan medical device registration consultant - IEC60601 series ,ISO0993 series, ISO 11135-1, ASTM F1140, ASTM F88, ISO 11737, ISO 7886-1…etc. - GMP application consultant - FDA submission/registration consultant - Taiwan medical device registration consultant - IEC60601 series ,ISO0993 series, ISO 11135-1, ASTM F1140, ASTM F88, ISO 11737, ISO 7886-1…etc.

  • Acute Ideas Co. Ltd./ Rumble Tuff
    • RA/QA
      • Apr 2016 - Aug 2017

      1. Build up, maintain, and improve ISO 13485:2016 quality system 2. FDA class II MD application 3. TFDA Class I/II MD product license application/renewal 4. Supplier management 4. ISO14971 :2012 risk management 5. QSD application 6. UDI label 7. Clinical trial evalution 8. CE MDD license application/renewal 1. Build up, maintain, and improve ISO 13485:2016 quality system 2. FDA class II MD application 3. TFDA Class I/II MD product license application/renewal 4. Supplier management 4. ISO14971 :2012 risk management 5. QSD application 6. UDI label 7. Clinical trial evalution 8. CE MDD license application/renewal

  • BIOTRONIK
    • Germany
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Sales Representative(Pacemaker)
      • Oct 2015 - Mar 2016

      1. Gain fundamental knowledge of disease management and able to convince customer with product features and benefits with scientific evidence (detailing aids). 2. Provide technical backup at follow-ups, clinics and implants as required if applicable. 1. Gain fundamental knowledge of disease management and able to convince customer with product features and benefits with scientific evidence (detailing aids). 2. Provide technical backup at follow-ups, clinics and implants as required if applicable.

Education

  • National Yang Ming University
    碩士, Biomedical/Medical Engineering
    2013 - 2015
  • National Yang Ming University
    學士, Life Science
    2009 - 2013

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