Candidate Opportunities

Regulatory Affairs Associate - 2019-003

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Lake County, IL
Job Type
Direct Hire
Apr 08, 2019
Job ID

Long standing company, known for long tenured employees; great growth potential.

Medical device and regulatory affairs experience are required!

Assists in the creation, implementation, monitoring and improvement of processes to ensure that released products meet regulatory requirements and facilitates compliance with complaint, MDR, and recall regulations.
  • The Regulatory Affairs Associate supports the Regulatory Affairs group and works under the direction of the Dept. Head to ensure Regulatory projects are completed in a thorough, accurate, and timely manner 
  • This individual assists in the creation, update, storage, organization, and maintenance of all regulatory documentation including, Project Applications, Product Cards, Device Master Records, Letters to File, and 510(k) submissions
  • Assists and supports all aspects of the complaint, MDR and recall processes including processing, reporting, trending, resolution, and documentation of all reportable and non-reportable incidents
  • Assists in the compilation of information to be submitted to regulatory authorities and help prepare regulatory submissions and / or responses 
  • Recommends and investigates solutions to quality and regulatory issues 
  • Works within the team to develop procedures and associated forms for assigned areas and assures their implementation
  • Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820 & ISO 13485
  • Aware of and comply with the Quality Manual and applicable laws and regulations as they apply to this job type/position.
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Other duties as assigned
  • B.S. Degree preferred; or 3-5 years appropriate experience necessary.
  • Working knowledge of 21 CFR 7, 803, 806, 810, and 820
  • Familiarity with processing and managing complaints, MDRs and / or filing 510ks and responding to FDA inquiries
  • Must have knowledge of Good Manufacturing Practices Requirements and experience in a regulated medical manufacturing environment
  • Excellent organizational skills and able to work independently
  • Excellent communication skills
  • Intermediate - Advanced PC experience with spreadsheets, letter writing and presentation applications.