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Regulatory Affairs Professional

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Job Title: Regulatory Affairs Specialist

We are seeking an experienced professional to fill a key role in our regulatory affairs department.

The successful candidate will have expertise in both pharmaceutical and medical device regulatory compliance, with the ability to prepare, review, and submit regulatory documentation to global health authorities.

Main Responsibilities:

  • Prepared and reviewed regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • E nsured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • Interacted with regulatory authorities during product submissions, inspections, and audits.
  • Developed and maintained regulatory strategies to support new product development and lifecycle management.
  • Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
  • Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
  • Supported quality systems in alignment with ISO 13485 and FDA QSR standards.
  • Collaborated with cross-functional teams to integrate regulatory requirements into product development.