Job Summary

Reg Affairs Specialist

  • Location:
    Warsaw, Indiana
  • Job reference:
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A Regulatory Affairs Specialist job in Warsaw, Indiana is available courtesy of Modis Engineering. Knowledge of Regulatory Information Management Systems (RIMS) are a MUST. Experience with pre-market regulatory requirements, ideally in orthopedic products, will be an advantage in this position. You will work to align regulatory procedures across multiple sites. The position will require strategic thinking and planning on how to approach the procedure alignment. This contract will run through the rest of the year and could possibly extend longer.

Regulatory Affairs Specialist job responsibilities include:
• Providing Regulatory Submission Support
• Assisting with Data Mapping and Data Migration from old system to new RIMS system
• Demonstrating high proficiency in technical writing and all communication
• Reviewing product changes to determine regulatory impact

• A Bachelor’s degree, ideally in a relevant discipline, is required
• A minimum of five years is desirable
• Experience with RIMS system such as PAREXEL or Inovia strongly preferred. US FDA submissions is strongly preferred.
• Knowledge of medical devices, particularly orthopedics, is preferred

If you are interested in this Regulatory Affairs Specialist job in Warsaw, Indiana then please click APPLY NOW. For other opportunities available at Modis Engineering go to If you have questions about the position, please contact Ray Sabio at 317-558-8868 or

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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