Regulatory Affairs Specialist

• Document Coordination: Collaborate with Division contacts to obtain essential documents required by Taiwan RAQA during the registration process, including license and QSD applications.
• Relationship Management: Establish and maintain a positive working relationship with Taiwan RA and Division peers to ensure timely support and document preparation.

Education & Special Trainings:

• Degree: At least a bachelors degree, preferably in healthcare, medical, engineering, or related fields.
• Knowledge: Basic understanding of ISO 13485 and US FDA regulations related to medical devices.

Qualifications & Experience:

• Experience: Minimum of 2 years of relevant regulatory and quality assurance experience in an international company.

Physical & Mental Requirements:

• Detail-Oriented: Strong attention to detail.
• Communication: Excellent communication skills.
• Influence: Ability to motivate others to take action.
• Ownership: Hands-on approach with the ability to implement swiftly and effectively by taking ownership and accepting responsibility.
• Ethics: High ethical standards and integrity.
• Organization: Well-organized with logical thinking.
• Planning: Good at planning processes, patient, and a strong sense of responsibility.