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Clinical Regulatory Affairs Associate

Post Date:Apr 21, 2017Type:Full-Time
Start Date:4/21/2017Salary:
Location:US-IL-Lake Forest Job Reference:1DCB42-Sy##

Minimum Education/Experience:

  • Bachelor's degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred.
  • 2+ years’ experience in a regulated industry (e.g., medical products, nutritional). This position does not require previous regulatory experience. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Job Description:

Primary Job Description:

  • The individual will support registration of in vitro diagnostic assays by reviewing and approving verification study reports, package insert/labeling, technical files and other documents, and submitting documentation on schedule as directed.
  • As an individual contributor; the function of a Regulatory Affairs Associate is to provide support for regulatory processes and procedures. The individual may execute tasks and exercise influence generally at the peer level.


Core Job Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 
  • Assist in SOP development, review and initiation
  • Stay abreast of regulatory procedures and changes in regulatory climate and update department
  • Investigate regulatory history of similar products to assess approval implications
  • Assist in monitoring and reporting project timelines
  • Respond to regulatory information requests
  • Monitor and utilize tracking and control systems
  • Organize materials from preclinical and clinical studies for review and assist in review process
  • Compile and organize materials for pre-submission reports
  • Coordinate and assist in the preparation of submission/registration packages
  • Coordinate registration requests and track completion
  • Oversee quality control of regulatory documents and submissions
  • Organize meetings with regulatory agency staff
  • Update and maintain global product listings; facility registrations; licenses/approvals; and annual registrations
  • Assist in the preparation of routine reports and regulatory agency communications
  • Update and maintain paper/electronic document archival systems
  • Prepare legal documents for import/export, registrations, tenders/bids or other purposes
  • Assist with review of promotional items
  • Coordinate internal audits and inspections
  • Assist with global vigilance reporting and regulatory field actions such as recalls or corrections & removals
  • May provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
  • Coordinate and support technical and scientific regulatory activities, research regulations and guidance and maintain and organize key information sources.
  • Works under general supervision, receives limited supervision on standard issues and detailed instructions on new assignments. Work is reviewed for soundness of judgment, overall adequacy and accuracy.


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Contact Information
Name: recruiter
Ph: 312-629-1020
FAX: 312-629-1028

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