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Regulatory Affairs Associate — CMC & PMA Expert

Job in Miami, Miami-Dade County, Florida, 33222, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-10-07
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 90000 - 150000 USD Yearly USD 90000.00 150000.00 YEAR
Job Description & How to Apply Below

Katalyst CRO is seeking a regulatory affairs professional to manage CMC dossiers, coordinate PMA submissions, and oversee CTD content for Class III implantable devices. This role requires collaboration with global teams and extensive experience with regulatory submissions.

You will lead complex documentation efforts, ensure compliance with US FDA PMA guidance, and drive project timelines across multiple initiatives.

This posting is for the Regulatory Affairs Associate — CMC & PMA Expert role at Katalyst CRO, based in Miami, FL, United States.

Step into the Regulatory Affairs Associate — CMC & PMA Expert role at Katalyst CRO in Miami, FL, United States and grow with us.

Please review the full job details above before applying.

If your experience matches this role, we encourage you to apply.

All applications are reviewed carefully by our team.

Position Requirements
10+ Years work experience
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