Regulatory Compliance Specialist

4 days ago


Irvine, California, United States Entegee Full time
Job Overview

We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Entegee. In this role, you will be responsible for managing submission publishing, device listings, and UDI data collection in the US and EU markets.

The ideal candidate will have 3-4 years of experience in Regulatory Operations within the medical device industry. A Bachelor's Degree is also required. Additionally, you should have experience with submission publishing, device listings, and UDI data collection and reporting. Familiarity with QMS updates and providing audit support for FDA, NB, and international agencies is also necessary. Proficiency in RIM systems, Power BI, and Business Objects is a plus.

Key Responsibilities:
  • Lead submission content management and submission publishing for US and EU markets.
  • Manage regulated master data, including UDI data collection and submission.
  • Assess new and changing regulations to ensure compliance.
  • Update regulatory processes and QMS procedures as needed.
  • Maintain device listings, product licensing, and facility registrations.
  • Provide audit support for FDA, NB, and international regulatory agency audits.

What We Offer:

We offer a competitive salary range of $45.00 to $55.00 per hour. Our comprehensive benefits package includes medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs.


Company Overview:

At Entegee, we specialize in custom automation projects and are a major player in the world of controls and robotic solutions around the world. We are committed to helping our associates grow and develop in their careers and offer opportunities for professional growth and development.



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