艾彼達健康科技顧問股份有限公司 是一家專注於醫療科技與人工智慧驅動健康科技創新的合同研究組織（CRO），提供從監管策略規劃、臨床方案設計、技術評估到市場准入支援的全方位解決方案，幫助客戶應對全球法規監管要求並實現商業成功。

我們現誠徵「醫材法規經理（Regulatory Affairs Manager）」，此職位為全職混合辦公（Hybrid），駐點台北。您將負責：

• 主導台灣（TFDA）、美國（FDA）及其他亞太市場醫療器材之法規策略規劃與申請文件撰寫
• 與研發、臨床及商務團隊協作，提供早期監管建議，參與產品與臨床方案設計、可行性評估及產品優化
• 定期追蹤國內外醫材法規與指引變動，制定合規路徑並維持與主管機關之良好溝通

如果您具備醫療器材監管申請經驗、熟悉TFDA/FDA法規，並對AI 驅動裝置或軟體醫療器材有熱忱，歡迎加入 AIBEDA，與我們一同助力創新醫療產品快速進入全球市場！

Role Description
This is a full-time hybrid role based in Taipei. The Regulatory Affairs Manager is responsible for leading regulatory strategy and submissions for medical devices in Taiwan (TFDA), the United States (FDA), and other Asia-Pacific markets. In addition to traditional regulatory responsibilities, the role plays a critical part in shaping product and clinical development strategies, particularly for innovative technologies such as AI-driven devices and software as a medical device (SaMD). By providing early-stage regulatory input, the role contributes to protocol design, clinical feasibility, and product refinement, ensuring alignment with both regulatory standards and commercial objectives.

Location: Taipei, Taiwan (Hybrid work model available)
Employment Type: Full-Time

Key Responsibilities

• Develop and implement regulatory strategies for Class I–III medical devices in Taiwan and the United States
• Prepare, review, and manage TFDA submissions (Class I & II) and FDA submissions (510(k), PMA, De Novo)
• Serve as liaison with regulatory authorities (TFDA, FDA), manage deficiency responses, and support audit readiness
• Advise clients during early product development on regulatory considerations that inform clinical protocol and product design
• Contribute regulatory insights to the development of SaMD, AI-powered devices, and other emerging technologies
• Support clinical study design, labelling, risk management, and evidence generation in alignment with regulatory requirements
• Monitor regulatory changes across global markets and assess their impact on client strategies
• Assist with the creation and maintenance of technical files and design documentation in compliance with ISO 13485 and MDSAP
• Oversee post-market surveillance and regulatory compliance where applicable

Qualifications

• Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field
• Minimum 5 years of experience in TFDA medical device submissions
• Demonstrated experience with U.S. FDA regulatory pathways, including 510(k), PMA, and De Novo
• Strong knowledge of ISO 13485, MDSAP, and applicable TFDA/FDA guidance
• Familiarity with SaMD, AI-based medical devices, and their evolving regulatory landscape
• Excellent written and verbal communication skills in both English and Mandarin
• Strong analytical thinking and the ability to provide strategic input during product and study design

Preferred Experience

• Regulatory submissions in other Asia-Pacific countries (e.g. Japan PMDA, South Korea MFDS, Singapore HAS, ASEAN MRA)
• Familiarity with EU MDR/IVDR and CE marking processes
• Experience contributing to cross-functional development teams (e.g. R&D, clinical, quality)

Why Join AIBEDA

• High-Impact Role: Combine regulatory leadership with influence on early-stage innovation
• Collaborative Culture: Engage with multidisciplinary teams in a flexible and dynamic environment
• Career Growth: Gain exposure to cutting-edge technologies, global markets, and strategic advisory work

Applications may be submitted to careers@aibeda.com with a CV and brief cover letter.