Senior Medical Device Compliance Expert

3 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Overview:

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to lead our medical device regulatory strategy.

The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions.

Must have a deep knowledge of regulatory requirements and processes for medical devices.

This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards, preparing regulatory submissions, and providing strategic regulatory guidance for new and existing products.

Key Responsibilities:
  • Lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices.
  • Prepare and 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.
  • Interface with FDA and other regulatory authorities to respond to inquiries and 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.
  • Develop and implement strategies for regulatory approvals in international markets, as needed.
Qualifications:
  • 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. 510(k) number will be requested to verify.
  • 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.
  • Ability to work independently and collaboratively in a cross-functional team environment.

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