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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Submission PublishingSubmission ManagementPDF manipulationDocument ManagementRIM systemsVeeva Vaultpublishing toolspublishing standardspublishing processesregulatory submission

Soft Skills

interpersonal skillseffective engagementproblem resolutioncommunication skillsguidance to junior staff

Tools & Technologies

Validation softwarePDF softwareDocument Management systemsRIM systems

Industry Keywords

regulatory operationsglobal worksharingagency guidancechanging regulationsbest practice guidance

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