Global Compliance Specialist

21 hours ago


Gurgaon, Haryana, India beBeeResponsibilities Full time ₹ 15,00,000 - ₹ 28,00,000
Regulatory Affairs Professional

About the Role:

We are seeking a skilled Regulatory Affairs Specialist to collaborate with our team in Taiwan. This role is crucial for ensuring compliance with regulatory requirements and facilitating smooth registration processes.

Key Responsibilities:

  • 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 positive working relationships with Taiwan RA and Division peers to ensure timely support and document preparation.

Qualifications & Experience:

  • Experience: Minimum of 2 years of relevant regulatory and quality assurance experience in an international company.
  • Education: Bachelor's degree or higher in healthcare, medical, engineering, or related fields.
  • Knowledge: Basic understanding of ISO 13485 and US FDA regulations related to medical devices.

Benefits:

  • 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.


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