Regulatory Affairs Specialist

Job Summary

A company is looking for a Specialist, RAQA.

Key Responsibilities

• Support post-market regulatory reporting activities, including adverse event reporting
• Lead communications with global regulatory authorities and participate in cross-functional projects
• Analyze complaint data and recommend corrective actions to address non-conformities

Required Qualifications

• University degree in engineering or science preferred
• Experience in medical device, biologics, or pharmaceutical fields preferred
• Knowledge of international regulations and standards (CFR, EU MDR, QSR, ISO 13485, MDSAP, etc.)
• Regulatory Affairs Certification and/or ASQ Certification preferred
• Prior experience working in a virtual/remote environment with minimal supervision