Regulatory Affairs & Clinical Data Manager

Job Summary

A company is looking for a Regulatory & Clinical Data Operations Manager.

Key Responsibilities

• Prepare and submit regulatory documentation, managing compliance with FDA and other certifications
• Serve as Clinical Research Associate (CRA) and manage healthcare datasets for clinical studies
• Coordinate cross-functional teams to ensure timely project execution and compliance

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Health Informatics, Regulatory Affairs, Data Science, or a related field
• Minimum of 1 year of experience as a Clinical Research Associate (CRA)
• 2-5 years of regulatory experience, including FDA submissions and ISO standards
• Proven experience managing EMR data and familiarity with the US healthcare system
• Strong proficiency in data management tools and visualization platforms