[Remote] Regulatory Affairs Specialist at GE Healthcare

Remote

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, SoftwareIndustries

Requirements

Bachelor's or Master's degree in STEM fields or equivalent
2+ years’ experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience
Strong verbal and written communication, and presentation skills in English
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications
Legal authorization to work in the U.S. (no sponsorship)

Responsibilities

Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets
Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements, product claims and country regulatory dependencies to ensure optimized sequencing for submissions
Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch
Implementation of regulatory changes from around the world, including assessing the impact of the changes on existing products
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements
Management of medical device shipments in accordance with regulatory approvals
Support for audits from various regulatory bodies

Skills

Regulatory Affairs

510(k)

MDR

Technical Files

NMPA

TGA

Quality Systems

Medical Devices

Regulatory Submissions

Product Compliance

Audits

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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