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.