Reporting Specialist II

Job Summary

A company is looking for a Reporting Specialist II.

Key Responsibilities:

• Make reportability decisions and lead vigilance reporting, including local and global submissions
• Partner with internal teams and manage complex reporting needs while ensuring stakeholder visibility
• Provide mentorship to Reporting Specialist I team members and seek process improvements

Required Qualifications:

• Bachelor's Degree strongly preferred in life sciences, pharmacy, nursing, or a related field
• 7+ years of experience in a cGMP related industry or clinical setting
• Knowledge of global regulatory requirements for pharmaceuticals and medical devices
• In-depth understanding of FDA Quality Systems and Medical Device Reporting regulations
• Ability to prioritize multiple projects ensuring compliance with regulations and procedures