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Regulatory Specialist I

Des Plaines, IL 60018

Posted: 04/08/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 604426 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $35-40/hr
 
Experience: 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

Skills:
  • Knowledge of regulations and standards affecting IVDs and/or biologics
  • Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.


Duties:
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides consultation/advice to regulatory specialist for change control and product development.
  • Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handles regulatory activities involved in documentation, labeling, field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Des Plaines, IL

Discover exciting job opportunities in the vibrant city of Des Plaines, Illinois! Nestled just north of Chicago, this bustling suburb offers a unique blend of urban convenience and small-town charm. From its close proximity to O'Hare International Airport to its diverse array of dining options featuring traditional Chicago deep-dish pizza, job seekers will find endless growth possibilities in this dynamic area. Explore the job listings today and unlock your potential in a region known for its rich cultural heritage, world-class museums like the Des Plaines History Center, lively entertainment venues like the Des Plaines Theatre, and easy access to recreational havens like Lake Opeka. Join the community and embrace a career in Des Plaines - where opportunity meets enchantment!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.