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Senior Regulatory Affairs Associate in Chicago, IL

Senior Regulatory Affairs Associate

(Chicago Area, IL)



This position is ideal for Ideal for someone looking to lead Regulatory strategy at the company’s facility located in the Chicago area.


This Regulatory Affairs Professional will be responsible for:

  • Development/Revision of 510k, regulatory filings and documentation processes including technical files
  • Letters/justifications to file, PMA supplements, and annual reports
  • International regulatory guidance’s and corresponding documentation
  • Regulatory guidance to research and operations staff
  • Device labeling and advertising input
  • Product and manufacturing change assessment
  • Regulatory support of Protocols and reports
  • Product complaints and management of reported adverse events and recalls
  • Communicate and coordinate regulatory activities with other departments to include
    • Design control
    • Risk assessment
    • Design and process validation
    • Regulatory assessments for Design History Files
  • Other duties as required



  • BS in science related field required
  • 3 years of medical device or biological sciences field is preferred
  • Involvement in the process of Regulatory submissions requirements and terminologies
  • Excellent organizational and project management skills with strong attention to detail
  • Regulatory Certification a plus

What Do You Want To Do Next?

  1. Submit your resume /Contact Lewie
  2. Download Six Tips for Investigating an Employer
  3. Search more jobs
  4. Learn how to Build a Happy Team
  5. Speak with someone about my staffing needs
  6. Learn about our full-time recruiting services

Contact Lewie/Submit Your Resume

Lewie Casey

Talent Manager

MEIRxRS 818-552-4173


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