Specialist - Regulatory Submissions Management

GE Medical Systems Polska Sp. z o.o.

🇺🇸 United States

Remote

2 weeks ago

Veeva
Veeva Vault

Pension

2 weeks ago

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Job Description Summary

As a Publishing Specialist within the Regulatory Submissions Management team, you will be responsible for providing regulatory submission publishing services in an efficient and timely manner. This role is a key point of contact for all customers of the Regulatory Operations group; and upholds “right first time” submission quality and timeliness. Your work will perform a pivotal role in achieving GE Healthcare’s Regulatory Strategies.

Job Description

Responsibilities:

Use Veeva for Registrations to plan and trackyour assigned submissions and effectively manageownworkload

Liaisewith Regulatory Affairs and local affiliates to provide them with Submissions Management and hands-onSubmissions Publishing support

WorkwithRegulatorySubmissionsManagement counterparts in other regions to facilitate global work-sharing

Provide customerswithbest practice guidance withinSubmissionPublishing, Document Management(using Veeva Vault) and submission-ready document standards

Support projects related to improving the publishing tools, standards, and processes

Monitor agency guidance & changing regulationsin assigned region

Required Qualifications:

1+year ofSubmission Publishing andSubmissionManagement principles ispreferred, withsomeknowledge offormats,standards, and processes inyour assigned region

Some hands-on experience withSubmissionPublishing, Validationand PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault) an advantage

Desirable Skills:

Goodinterpersonal skills and ability toengage effectively with peers

Ability to resolvemostday-to-day issues, escalatingto peers and/or supervisors as needed

Good IT skills, with the ability to learn new tools and systems quickly

Experience working with outsource partnersan advantage

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $62,400.00-$93,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided:No

Application Deadline: September 25, 2026

Specialist - Regulatory Submissions Management · GE Medical Systems Polska Sp. z o.o.

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