Regulatory Affairs Coordinator in Waukegan, IL at APEX Systems

Date Posted: 9/8/2019

Job Snapshot

Job Description

Job #:  986907


Responsibilities: 
  • Coordinate Drug Stability Testing with cross functional teams
  • Validate FDA drug regulatory data on new and existing components 
  • Complete Component Qualification process for Presource convenience kits
  • Update component files with supplier documentation/scanning of documentation 
  • Coordinate and complete projects
  • Work with team members and cross functional teams to achieve goals

Qualifications: 
  • Demonstrates knowledge of FDA regulation for drugs and stability requirements
  • Demonstrates knowledge of FDA regulation for medical devices
  • Familiar with Registration and listing of medical devices with the FDA process, highly preferred
  • Background with UDI, preferred 
  • Strong Microsoft Office and Excel skills, proficient with query writing an excel formulas (vlookup, pivot table, etc.)
  • Strong written and verbal communication skills
  • Ability to communicate within all levels of CAH regulatory organization including senior leadership
  • Experience in creating protocols, procedures, policies, forms, preferred
  • Detail-oriented; Excellent organizational and follow up skills
  • Quick learner; able to retain and apply knowledge 
  • Works with minimal supervision and when in doubt asks for guidance 
  • Strong time management and multi-tasking skills. 
  • Ability to follow established policies, processes, and procedures. 

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.