Candidate Opportunities

Regulatory Affairs Associate - 2019-003

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Location
Lake County, IL
Job Type
Direct Hire
Date
Apr 08, 2019
Job ID
2653221

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

Medical device and regulatory affairs experience are required!

DESCRIPTION:
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.
 
REQUIREMENTS AND RESPONSIBILITIES:
  • 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
 
ADDITIONAL RESPONSIBILITIES:
  • 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
 
QUALIFICATIONS:
  • 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.