Senior Specialist – Regulatory Submissions Management

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $73.6k - $110.4k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• 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

• 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

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