Regulatory Affairs Manager Position

3 days ago

Surat, Gujarat, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000
Regulatory Compliance Specialist Role

The ideal candidate will be responsible for ensuring our medical devices meet local and international regulatory standards.

  • Develop strategic approaches to regulatory compliance for new/existing products.
  • Verify adherence to local/international regulations (CDSCO, ISO, FDA).
  • Prepare and submit comprehensive regulatory submissions.
  • Monitor regulatory developments and adjust strategies accordingly.
  • Collaborate with regulatory bodies and internal teams for seamless compliance.
  • Conduct thorough audits and maintain up-to-date knowledge of regulatory requirements.

To excel in this role, you should possess a Bachelor's degree in a scientific discipline, along with 2 to 3 years' experience in regulatory affairs within the medical device industry. In-depth knowledge of CDSCO, ISO, and FDA standards is essential, as well as expertise in regulatory submissions and medical device development. Exceptional communication, organizational, and project management skills are also required.

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