Yuan-Ming Hsu Phd
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Yuan-Ming Hsu Phd Email & Phone Number

Senior Manager (Marketing and RA and Clinical) at twsc
Location: Taipei, Taipei City, Taiwan, Province of China 10 work roles 2 schools
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Role
Senior Manager (Marketing and RA and Clinical)
Location
Taipei, Taipei City, Taiwan, Province of China
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Yuan-Ming Hsu Phd is listed as Senior Manager (Marketing and RA and Clinical) at twsc, a with 28 employees, based in Taipei, Taipei City, Taiwan, Province of China. AeroLeads shows a matched LinkedIn profile for Yuan-Ming Hsu Phd.

Yuan-Ming Hsu Phd previously worked as R&D Director at Medical Devices Industry and Senior Director of Research and Development at Hcmed Innovations Co., Ltd.. Yuan-Ming Hsu Phd holds Doctor Of Philosophy (Phd), Biomedical/Medical Engineering from National Yang Ming University.

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twsc

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About Yuan-Ming Hsu Phd

In my current role, I lead the RD1 department, focusing on developing new products and securing drug and medical device approvals in various regions and markets.I am experienced in the activities required during medical product development (pharmaceutical and medical device), including risk management, design matrix, product and usability specification, design verification/validation tests, and so on. In addition, I have experience of internal/external audits and due diligence.From the experience of the previous jobs, I am familiar with regulations and guidance (such as GCP) of cellular therapy and medical device announced by FDA, ICH, CE and TFDA. I am able to initiate a phase I or II clinical trial from designing protocol, defining objectives, estimating sample size, communicating with PIs and CRO, preparing documents, applying IND/IDE trials, and replying to IRBs/ECs and authorities (such as FDA/TFDA).From the experience of graduate school to the current job, I am capable of designing and conducting pre-clinical studies including toxicology, pharmacology, and potency tests for specific indications of cell therapy (neurodegenerative diseases, liver failure, etc) and biocompatibility, feasibility, and safety tests of medical devices through in vitro and in vivo assays.Well trained project management and people skills.

Listed skills include Cell Culture, Microscopy, Biomaterials, Research, and 21 others.

Current workplace

Yuan-Ming Hsu Phd's current company

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twsc
Twsc
Senior Manager (Marketing and RA and Clinical)
Taipei City, Taiwan
Website
Employees
28
AeroLeads page
10 roles

Yuan-Ming Hsu Phd work experience

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Senior Manager (Marketing And Ra And Clinical)

Taipei City, Taiwan

Senior Director Of Research And Development

台灣 臺北市 大安區

- Lead R&D team (EE/SW/ME/DQE/IP) on the development and optimization of existing products.- Propose and supervise the development of new products through the whole product life cycle.- Supervise in-house aerosol performance testing labs located in Taiwan headquarter and UK subsidiary.- Set up budget and goals of R&D projects, assuming implications on risk management, quality, and timelines.- Supervise the clinical trials from study initiation, site start-up, and implementation.- Engage in cross-department communication to facilitate and coordinate product development.- Assist in document review and revision, including documentation required on regulatory purposes and project execution.- Person responsible for regulatory compliance, PRRC.

Jan 2024 - Jun 2024

Director Of Research And Development

台灣 臺北市

- Lead R&D team on the development and optimization of existing products.- Propose and supervise the development of new products through the whole product life cycle.- Set up budget and goals of R&D projects, assuming implications on risk management, quality, and timelines.- Supervise the clinical trials from study initiation, site start-up, and implementation.- Engage in cross-department communication to facilitate and coordinate product development.- Assist in document review and revision, including documentation required on regulatory purposes and project execution.- Person responsible for regulatory compliance, PRRC.

Jan 2020 - Dec 2023

Senior Manager

Medeon Biodesign, Inc.

Taipei, Taiwan

Project manager of an across company project (with Terumo Medical Corporation, USA). Clinical affairs, including study design, submission preparation and implementation. (Completed a CE study and involved in a IDE study)R&D, including device history file, device quality and biocompatibility tests, device shelf-life evaluation and pre-clinical studies.

Feb 2018 - Dec 2019

Manager

Medeon Biodesign, Inc.
Mar 2016 - Jan 2018

Senior Manager

Taipei City, Taiwan

Head of Research & Development Department, responsible for IP patenting and licensing, pre-clinical R&D studies and clinical trials sponsored or supported by company, and handling the budget of this department.

Jul 2014 - Feb 2016

Manager

Taipei City, Taiwan

Management of pre-clinical efficacy/toxicity studies and 4 early phase clinical trials sponsored or supported by company, including project (1) design; (2) budget control; (3) time plan; (4) implementation and monitoring; (5) analysis & report.

Nov 2013 - Jun 2014

Researcher

Far Eastern Memorial Hospital

My research areas of interests include biomedical engineering, biomaterials development and testing, and stem cell application in orthopaedics. I focus on investigating the bone repair with mesenchymal stem cell with different biomaterials. Since 2009, as a researcher in FEMH, I heavily involves in the study of cartilage reconstruction, and the application of biomimetic scaffolds in articular cartilage repair. In addition, I also collaborates with some research units or manufacturers in developing orthopedic products.

Aug 2009 - Oct 2013
Team & coworkers

Colleagues at twsc

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2 education records

Yuan-Ming Hsu Phd education

FAQ

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What company does Yuan-Ming Hsu Phd work for?

Yuan-Ming Hsu Phd works for twsc.

What is Yuan-Ming Hsu Phd's role at twsc?

Yuan-Ming Hsu Phd is listed as Senior Manager (Marketing and RA and Clinical) at twsc.

Where is Yuan-Ming Hsu Phd based?

Yuan-Ming Hsu Phd is based in Taipei, Taipei City, Taiwan, Province of China while working with twsc.

What companies has Yuan-Ming Hsu Phd worked for?

Yuan-Ming Hsu Phd has worked for Twsc, Medical Devices Industry, Hcmed Innovations Co., Ltd., Medeon Biodesign, Inc., and Steminent Biotherapeutics.

Who are Yuan-Ming Hsu Phd's colleagues at twsc?

Yuan-Ming Hsu Phd's colleagues at twsc include Po-Chun Chia, 溫譽玲, Max Lin, Coby Hsu, and Tso Ju-Chun Carol.

How can I contact Yuan-Ming Hsu Phd?

You can use AeroLeads to view verified contact signals for Yuan-Ming Hsu Phd at twsc, including work email, phone, and LinkedIn data when available.

What schools did Yuan-Ming Hsu Phd attend?

Yuan-Ming Hsu Phd holds Doctor Of Philosophy (Phd), Biomedical/Medical Engineering from National Yang Ming University.

What skills is Yuan-Ming Hsu Phd known for?

Yuan-Ming Hsu Phd is listed with skills including Cell Culture, Microscopy, Biomaterials, Research, Biomedical Engineering, Cell Biology, R&D, and Biochemistry.

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