Regulatory Operations Expert

7 days ago


Irvine, California, United States Entegee Full time

Job Title: Sr Regulatory Operations Specialist

Job Summary:

Entegee is seeking an experienced Sr Regulatory Operations Specialist to join our team. In this role, you will be responsible for managing submission publishing, device listings, UDI data collection, and maintaining regulatory compliance for medical devices in the US and EU markets.

Responsibilities:

  • Lead submission content management and submission publishing for US and EU markets
  • Manage regulated master data, including UDI data collection and submission
  • Audit and assess new and changing regulations to ensure compliance
  • Update regulatory processes and QMS procedures as needed
  • Maintain device listings, product licensing, and facility registrations
  • Collaborate with cross-functional teams to prepare submission content and maintain overall regulatory compliance

Benefits:

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

Equal Opportunity Employer: Entegee is an Equal Opportunity Employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.



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