Regulatory Affairs Associate

3 weeks ago

Lake Forest, United States GForce Life Sciences Full time

Regulatory Affairs Associate JR Lake Forest, IL

MUST BE ABLE TO WORK ON A W2

Job Title: Regulatory Affairs Associate JR

Job Summary:

The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics associated with the process for Executive Management Review (EMR) and completes final signature approval of an ePAS package (i.e., FSG Approval). Additionally, the role involves data review, analysis, and verification.

Qualifications:

  • Education: Minimum BS in engineering or scientific degree
  • Experience: Minimum 1+ years experience in a medical device or similarly regulated industry
  • Skills:
  • Strong analytical and problem-solving skills
  • Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams
  • Effective verbal and written communication skills, with the ability to communicate with diverse audiences and personnel and write/edit technical documents
  • Ability to work with people from various disciplines and cultures
  • Strong attention to detail and good organizational/project management skills to manage and track a wide range of tasks, develop realistic action plans, and prioritize work activities

Responsibilities:

  • Manage regulatory submissions to ensure timely regulatory approval of medical devices
  • Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams
  • Ensure all client products and procedures comply with applicable regulatory agency requirements and guidelines

Term & Start

  • 6- month contract
  • FT, M-F 40hr/week
  • Pay Rate: $20-25/HR
  • Onsite in Lake Forest, IL

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