Regulatory Compliance Specialist

2 days ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Role Summary:

This position entails the compilation, review, and submission of pre-meeting packages for authority meetings. The role also involves participating in relevant meetings and handling change requests, non-conformities, and CAPA cases.

Key Responsibilities:
  • Pre-Meeting Packages: Compile, review, and submit pre-meeting packages to ensure accuracy and compliance with regulatory requirements.
  • Meeting Participation: Participate in authority meetings as necessary, contributing to discussions and decision-making processes.
  • Change Requests: Handle change requests, non-conformities, and CAPA cases within the assigned area of responsibility, ensuring timely resolution and documentation.
  • Document Review: Review device documentation, protocols, and reports to assess their appropriateness for specific regulatory purposes.
Skills and Qualifications:
  • Regulatory Knowledge: Possess a strong understanding of regulatory requirements and guidelines.
  • Communication Skills: Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Analytical Skills: Strong analytical skills, with the ability to interpret complex data and regulations.
Benefits:
  • Competitive Salary: Receive a competitive salary package.
  • Opportunities for Growth: Opportunities for career growth and professional development.


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