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Honeywell Sr FDA Regulatory Specialist in Smithfield, Rhode Island

The future is what you make it.

When you join Honeywell, you become a member of our global team of thinkers, innovators, dreamers and doers who make the things that make the future.

That means changing the way we fly, fueling jets in an eco-friendly way, keeping buildings smart and safe and even making it possible to breathe on Mars.

Working at Honeywell isn’t just about developing cool things. That’s why all of our employees enjoy access to dynamic career opportunities across different fields and industries.

Are you ready to help us make the future?

Be a part of our global Regulatory Compliance Team that applies its expertise and knowledge in finding innovative, cost-effective means to improve regulatory compliance, quality output and continuous improvement. Specific responsibilities include but are not limited to:

  • Support new product development/modifications projects

  • Ensure all regulatory data and documents are compliant to FDA Regulations

  • Ensure all certifications and supporting documentation are established and maintained in our certification management system.

  • Demonstrate working knowledge of cGMP’s and other documentation essential to providing evidence of compliance with FDA regulations

  • Responsible for Global Unique Device Identification Database (GUDID)

  • Work close with FDD regulatory compliance engineers to assure compliance with regulatory agencies

  • Create, review and revise all functional group SOP’s

YOU MUST HAVE

  • High School Diploma / GED

  • 2+ years regulatory knowledge including familiarity with Code of Federal Regulations

  • 2+ years experience FDA

WE VALUE

  • Good organizational skills and the ability to prioritize with changing situations

  • Ability to handle confidential information in a professional manner

  • Advanced Education

  • Detailed oriented and highly self-motivated

  • Strong attention to detail

SPSHealthcare

Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.

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