Arthur Wu

Regulatory Affairs professional with 13+ years of experience in medical device regulatory affairs, including Taiwan medical device registration, license renewal and variation, QSD submissions, quality systems, and international regulatory activities.

Former Assistant

Reviewer at the Taiwan Food and Drug Administration (TFDA), Medical Device Division, with direct experience in GMP and QSD case review and first-hand understanding of Taiwan regulatory requirements and review expectations. Hands-on experience preparing and managing Taiwan medical device registration dossiers, QSD applications, renewals and regulatory documentation. Proven ability to interpret regulatory requirements, identify submission issues, conduct regulatory research, and coordinate with internal teams, external consultants, and regulatory authorities.

Experienced in supporting international medical device registration projects and communicating regulatory matters with overseas stakeholders in English.

Regulatory Affairs Specialist / Product Manager at Deep01 Limited (2020-06 – 2024-05)

• Managed Taiwan medical device registration, change and renewal applications throughout the product lifecycle.
• Led the establishment and registration of the company’s Taiwan Quality Management System (QMS) and successfully obtained certification.
• Led ISO 13485 establishment and certification, coordinating regulatory, quality and cross-functional activities.
• Coordinated with an external regulatory consulting firm to conduct CE MDR registration and application activities.
• Supported medical device registrations in Japan, Malaysia, Thailand and other international markets.
• Coordinated with R&D, QA, manufacturing and external parties to resolve regulatory and technical issues and ensure regulatory readiness.

Planned Family Caregiver Career Break at Career Break (2018-05 – 2020-05)

Director of Operations at Basic Apparel Inc. (2016-05 – 2018-04)

• Managed company operations, product development and cross-functional project execution.
• Coordinated product development activities from design and sampling through procurement and final production.
• Developed experience in project planning, stakeholder coordination, operational management and execution.

Senior Regulatory Affairs Specialist, MA Department at Covidien Taiwan Ltd. (acquired by Medtronic) (2014-12 – 2016-05)

• Managed Taiwan medical device registration submissions, including preparation of administrative and technical regulatory documentation.
• Successfully obtained 5 new medical device licenses.
• Completed 20+ license renewal applications and filed 10+ license variation applications.
• Managed QSD submissions and renewals, successfully completing 5+ QSD applications/renewals.
• Coordinated regulatory activities with external regulatory consultants and third-party service providers.

Senior Regulatory Affairs Specialist / Quality Assurance Specialist, MA Department at Fresenius Kabi Taiwan Ltd. (2012-02 – 2014-12)

• Prepared and submitted Taiwan medical device registration applications and supporting administrative and technical documentation.
• Successfully obtained 8 new medical device licenses.
• Completed 5+ license renewal applications and filed 3+ variation applications.
• Managed QSD submissions and renewals, successfully completing 3+ QSD applications/renewals.
• Established and maintained SOPs and regulatory/quality compliance documentation.
• Conducted internal audit and quality compliance activities.
• Managed product complaint handling and post-market surveillance activities.

Regulatory Affairs Specialist, RA & GA Department at Alcon Pharmaceuticals Ltd., Taiwan Branch (2011-10 – 2012-02)

• Supported regulatory affairs activities and regulatory documentation for products in Taiwan.
• Assisted with regulatory submissions and communications in accordance with applicable requirements.

Assistant Reviewer, Medical Device Division at Taiwan Food and Drug Administration (TFDA) (2011-02 – 2011-10)

• Reviewed medical device GMP and QSD cases in accordance with Taiwan regulatory requirements.
• Developed first-hand understanding of TFDA review procedures, regulatory interpretation, submission requirements and agency expectations.
• Communicated with applicants regarding regulatory documentation and review issues.

B.S. in Biomedical Engineering – Case Western Reserve University (2003 – 2007)