I-Hsun Chen

I-Hsun Chen Email and Phone Number

RAQA Associate CooperVision
I-Hsun Chen's Location
Taiwan, Taiwan, Province of China
About I-Hsun Chen

Dedicated Regulatory Affairs and Quality Assurance (RAQA) professional with over 3 years of experience in the Medical Device industry. Proven track record in achieving regulatory compliance, quality management, and international project coordination. Seeking opportunities to leverage my expertise in navigating complex regulatory landscapes, optimizing quality processes, and driving successful product approvals.HIGHLIGHT- Successfully handled over 30 Class II license renewal cases, maintaining timely approvals.- Submitted and secured approvals for over 20 Class II license change cases, including specific modifications and package changes.- Achieved QSD approvals for more than 10 cases, demonstrating expertise in quality and compliance.ACHIEVEMENTS- Collaborated with COVAX and Health Authority on COVID-19 Vaccine Emergency Use Authorization during the pandemic.- Increased Serious Adverse Event (SAE) reporting efficiency by 75% through process optimization.- Achieved 100% compliance and timely approvals for product and facility licenses.- Reduced submission dossier application time by 30% through process streamlining.

I-Hsun Chen's Current Company Details

RAQA Associate CooperVision
I-Hsun Chen Work Experience Details
  • Coopervision
    Raqa Associate
    Coopervision May 2022 - Jan 2024
    Regulatory- Maintain the effectiveness of product license and facility license.- Work with global/ regional RA to conduct the UDI requirement.- Organize the submission dossier on the quality management system (Agile, Veeva).- Manage the package material to qualify the local requirement.Quality Assurance- Establish and optimize the local procedures.- Provide advices to logistic team for rising the awareness of quality.- AEs/ compliant cases handling. Monitor the post-approval product and provide the feedback to global team on time.
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  • Zuellig Pharma
    Regulatory& Government Affairs
    Zuellig Pharma Feb 2021 - Apr 2022
    Regulatory- Cooperates with Health Authority on the COVID-19 project.- Maintain the license, work with client internationally to apply the extension of product licenses and facility approvals.- Collaborate with the Business Development team and the Regional RA team to evaluate the new product project. Providing the professional information and suggestion for the teams.- Organize the promotion material code systematically and work with the medical team with the materiel management.Pharmacovigilance- The primary contact of the PV to the client and report directly to regional PV lead.- Assisted the client in establishing the file format of the ICH E2B (R3) for the Taiwan ADRs reporting system which increased the effectiveness of case reporting by 75%
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  • Guerbet
    Regulatory Affairs
    Guerbet Jun 2020 - Jan 2021
    Regulatory- Applied for NHI reimbursement regarding medical device. Provided relevant regulatory information and suggestions for marketing and sales teams to formulate business strategies.- Handled adding domestic or foreign secondary package site plans for drugs by providing regulatory information and evaluation strategies.- Evaluated the strategy for license application in Taiwan for medical device that outsourced secondary packaging abroad.- Monitor and analysis the regulations change. Providing the comments and solutions to the stakeholders.Quality Assurance- Maintained Good Distribution Practice (GDP) approval.- Wrote a drug recall procedure to handle quality warnings and defective product recycling.Pharmacovigilance- Managed ADR cases. Uploaded cases to the Taiwan ADRs reporting system.- Completed signal detection report of PV. Analyzed and monitored for abnormalities based on reports.
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  • Weidar Chemical & Pharmaceutical
    Development Coordinator
    Weidar Chemical & Pharmaceutical Jun 2018 - May 2020
    - Assisted with the application for adding the manufacture of new dosage form for GMP.- Applied manufacture site change and change form for compliance.- Built a food traceability system and process according to regulations by the effective date.- Organized GMP, GDP, ISO 22000, and ISO 9001 documents.

I-Hsun Chen Education Details

Frequently Asked Questions about I-Hsun Chen

What is I-Hsun Chen's role at the current company?

I-Hsun Chen's current role is RAQA Associate CooperVision.

What schools did I-Hsun Chen attend?

I-Hsun Chen attended Chung Shan Medical University.

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