Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist - Vigilance.

Key Responsibilities

• Coordinate and document internal regulatory processes, including audits and license renewals
• Prepare and review regulatory submissions for domestic and international projects
• Support global vigilance activities, focusing on adverse event monitoring and reporting

Required Qualifications

• Bachelor's degree in regulatory affairs or related field
• One year of experience with medical device safety signaling and regulatory submissions
• One year of experience in gap assessments and developing regulatory strategies for medical devices
• One year of experience in pharmaceutical quality assurance practices
• Six months of experience conducting internal and external audits