Regulatory Affairs Expert Wanted

2 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 7,50,000 - ₹ 12,50,000
Senior Regulatory Specialist Role

We are seeking a highly skilled and experienced professional to lead our regulatory affairs team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions.

This role involves 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 authorizing 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.

Preferred Qualifications:

  • RAC (Regulatory Affairs Certification) or similar professional certification.
  • Experience with international regulatory submissions (e.g., CE marking, Health Canada).

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