Senior Regulatory Compliance Specialist

15 hours ago


Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 12,34,567 - ₹ 25,84,893
Regulatory Affairs Manager

We are seeking a skilled regulatory affairs specialist to author, manage and receive clearances for FDA 510(k) submissions.

About the Role
  • Prepare, submit and manage FDA 510(k) premarket notifications for medical devices.
  • Review regulatory documentation to ensure compliance with FDA regulations and standards.
  • Advise product development teams on regulatory requirements and strategy throughout the product lifecycle.
  • Maintain up-to-date knowledge of FDA regulations, guidance documents and industry best practices.
Key Responsibilities
  • Interface with FDA and other regulatory authorities to resolve regulatory issues.
  • Ensure timely submission of regulatory filings, meeting project deadlines and milestones.
  • Support internal audits and inspections related to regulatory compliance.
  • Review labeling and promotional materials to ensure compliance with regulatory requirements.
Requirements
  • Bachelor's degree in Life Sciences, Engineering or a related field.
  • Minimum of 5-7 years of regulatory affairs experience in the medical device industry.
  • Proven experience in authoring and managing FDA 510(k) submissions.
  • Strong understanding of FDA regulations, including 21 CFR Part 820, 21 CFR Part 807 and related guidance.


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