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Compliance Specialist

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Job Title: Regulatory Compliance Manager

Overview:

We seek a seasoned professional with expertise in regulatory affairs for pharmaceuticals and medical devices.

The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.

Key Responsibilities:

  • Prepared regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • Ensured compliance with international, federal, and local regulatory requirements across industries.
  • Interacted with regulatory authorities during product submissions, inspections, and audits.
  • Developed regulatory strategies to support new product development and lifecycle management.
  • Reviewed labeling and promotional materials for compliance.
  • Maintained up-to-date knowledge of regulatory changes and industry best practices.
  • Supported quality systems aligned with ISO standards.
  • Collaborated with cross-functional teams to integrate regulatory requirements.
  • Managed regulatory documentation archives and maintained compliance records.