Job Details

A company is looking for a Reporting Specialist II.Key Responsibilities:Make reportability decisions and lead vigilance reporting, including local and global submissionsPartner with internal teams and manage complex reporting needs while ensuring stakeholder visibilityProvide mentorship to Reporting Specialist I team members and seek process improvementsRequired Qualifications:Bachelor's Degree strongly preferred in life sciences, pharmacy, nursing, or a related field7+ years of experience in a cGMP related industry or clinical settingKnowledge of global regulatory requirements for pharmaceuticals and medical devicesIn-depth understanding of FDA Quality Systems and Medical Device Reporting regulationsAbility to prioritize multiple projects ensuring compliance with regulations and procedures