Regulatory Reporting Specialist

Job Summary

A company is looking for a Regulatory Specialist to manage regulatory reporting and compliance in the medical device sector.

Key Responsibilities

• Review and assess customer complaints for regulatory reporting
• Submit reports to regulatory agencies and process additional information requests
• Analyze complaint data and recommend corrective actions to address non-conformities

Required Qualifications

• Bachelor's degree required; engineering or science degree preferred
• Experience in the medical device, biologics, or pharmaceutical fields preferred
• Proficiency in Microsoft Office, particularly Excel and PowerPoint
• Knowledge of international regulations and standards (e.g., CFR, EU MDR, ISO 13485)
• Regulatory Affairs Certification and/or ASQ Certification preferred