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Regulatory Affairs Specialist

La Porte, IN 46350

Employment Type: Permanent Hire Industry: Industry Job Number: 7927 Pay Rate: 65,000

Regulatory Affairs Specialist

Are you an experienced Regulatory Affairs Specialist looking for a  challenging opportunity with an industry leader?  If you have a least 3 years’ experience in Regulatory Affairs and are looking for a growing company with a great corporate culture, then keep reading!

Located in La Porte, IN, this role reports to the Quality Assurance and Regulatory Affairs Manager, and will be responsible for preparing regulatory submissions for modified and new medical devices for markets around the world.

What’ s in it for you?
  • Ability to work with a world renown industry leader with over 75 years’ experience
  • Excellent compensation including bonus program 
  • Flexible schedule
  • Complete and comprehensive benefits program
  • Many unique employee perks

What you will be doing?
  • Our Regulatory Specialist Prepares regulatory submissions for modified and new medical devices in US and for international regulatory agencies.
  • Our Regulatory Specialist Works with document control specialists and quality engineers to obtain necessary information for submissions.
  • Our Regulatory Specialist  Manages technical files and content to maintain compliance.
  • Our Regulatory Specialist  Coordinates the preparation of additional information requested by FDA or international regulatory agencies.

What you need for this position?
  • 3 years Regulatory Affairs experience with medical devices required
  • Experience working with both US and international regulations
  • Strong verbal and written communication skills
  • Very organized and detail oriented

Send resume for review to Amy Szuba at


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