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February 3rd, 2017

Senior Regulatory Affairs Associate

(Chicago Area, IL)

 

Summary:

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

 

Requirements:

  • 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
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  5. Speak with someone about my staffing needs
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Contact Lewie/Submit Your Resume

Lewie Casey

Talent Manager

MEIRxRS

lcasey@meirxrs.com 818-552-4173

 

Fill out my online form.

 

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