Job Responsibilities

1. Regulatory Submission & Compliance:

- Be responsible for the preparation, compilation, and submission of all regulatory dossiers for both medical devices and pharmaceuticals, including product registrations, site registrations, license maintenance, and product variations.

- Timely tracking and reporting of submission status and progress to stakeholders. 2. Strategic Regulatory Planning:

- Support in creation of regulatory strategy for the company's product portfolio including product renewals, ensuring streamlined cross-functional collaboration for business continuity and accelerate market entry.

3. Internal and External Coordination:

- Efficiently communicate and collaborate with the Product Center RA team for all regulatory needs and ensure accurate and complete dossier collection.

- Act as the primary liaison for communication with the TFDA and actively maintain networking with the local industry community.

Requirements

➢ Work experience: Minimum of 5 years of hands-on experience in the above Regulatory Affairs related work in Taiwan.

➢ Educational Requirements: Bachelor's or Master's Degree ➢ Academic Requirement: Science-related, Pharmacy, Medical-related, or a related discipline. ➢ Language Proficiency: Chinese: Native speaker, and English — Listening / Fluent, Speaking / Fluent, Reading / Fluent, Writing / Fluent

➢ Proficient in : Excel、Outlook、PowerPoint、Word

➢ Core Competencies: Solid knowledge and understanding of relevant Medical Devices or Pharmaceutical regulations (e.g., TFDA, US FDA, EU MDR, etc.).

➢ Others:

1. Excellent interpersonal, writing, and verbal communication skills are required.

2. Highly capable of prioritizing projects and efficiently managing multi tasks.

3. Proven ability to deliver results on time in a fast-paced environment.

4. Ability to interact with internal and external business partners in a professional and collaborative manner.