Senior Regulatory Professional

1 week ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Affairs Specialist Job Summary

We are seeking a skilled professional to lead regulatory affairs for medical devices.

Main Responsibilities:
  • Prepare and submit FDA 510(k) premarket notifications for new products.
  • Ensure compliance with FDA regulations, standards, and guidelines through documentation review and management.
  • Provide strategic advice on regulatory requirements and product development throughout the lifecycle.
  • Maintain up-to-date knowledge of FDA regulations, guidance documents, and industry best practices.
  • Interface with FDA and other regulatory authorities to respond to inquiries and resolve issues.
  • Coordinate timely submission of regulatory filings, meeting project deadlines and milestones.
Qualifications and Requirements:
  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • Minimum 5-7 years of regulatory affairs experience in medical devices.
  • 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.
  • Ability to interpret and apply regulatory requirements to complex technical issues.
  • Excellent communication, organization, and problem-solving skills.
  • Experience in preparing responses to FDA queries and managing interactions with regulatory authorities.

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