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GE HealthCare

Senior Specialist – Regulatory Submissions Management

GE HealthCare

Senior Publishing Specialist providing regulatory submission publishing services for GE HealthCare. Ensuring quality and timeliness while liaising with Regulatory Affairs and local affiliates.

Posted 6/10/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $73,600 - $110,400 per yearWebsite

Tech Stack

Tools & technologies
Vault

About the role

Key responsibilities & impact
  • provide regulatory submission publishing services in an efficient and timely manner
  • key point of contact for all customers of the Regulatory Operations group
  • uphold “right first time” submission quality and timeliness
  • liaison with Regulatory Affairs and local affiliates for support
  • work with counterparts in other regions to facilitate global worksharing
  • provide best practice guidance within Submission Publishing and Document Management
  • provide guidance to junior staff members
  • support projects related to improving publishing tools, standards, and processes
  • monitor agency guidance & changing regulations in assigned region

Requirements

What you’ll need
  • 2+ years of Submission Publishing and Submission Management principles
  • good knowledge of formats, standards, and processes
  • hands-on experience with Submission Publishing
  • Validation and PDF manipulation software
  • Document Management and RIM systems (e.g., Veeva Vault)
  • good interpersonal skills
  • ability to engage effectively with peers
  • ability to resolve day-to-day issues
  • good IT skills, with the ability to learn new tools and systems quickly
  • experience working with outsource partners an advantage
  • good proficiency in spoken and written English
  • willing to attend local GE Healthcare office on an ‘as-needed’ basis
  • willing to travel when required, but not more than 5%

Benefits

Comp & perks
  • medical
  • dental
  • vision
  • paid time off
  • a 401(k) plan with employee and company contribution opportunities
  • life
  • disability
  • accident insurance
  • tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
Submission PublishingSubmission ManagementPDF manipulationDocument ManagementRIM systemsVeeva Vaultpublishing toolspublishing standardspublishing processesregulatory submission
Soft Skills
interpersonal skillseffective engagementproblem resolutioncommunication skillsguidance to junior staff