Regulatory Affairs Specialist at GE Healthcare

Seongnam, South Korea, South Korea

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Basic experience in Quality & Regulatory Affairs
Knowledge level comparable to a Bachelor's degree from an accredited university or college (or a high school diploma with relevant experience)
Strong oral and written communication skills
Ability to document, plan, market, and execute programs

Responsibilities

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations, and postmarket compliance
Works closely with healthcare regulatory bodies globally
Applies general knowledge of business developed through education or past experience
Understands how work of own team contributes to the area
Resolves issues using established procedures and consults People Leader or more senior team members for issues outside of defined parameters
Collaborates with others to solve issues
For customer-facing roles, develops strong customer relationships and serves as the interface between customer and GE
Exchanges technical information, asks questions, and checks for understanding
Handles simple data entry work requiring face value check and correction

Skills

Regulatory Affairs

Healthcare Regulations

Premarket Submissions

Postmarket Compliance

Regulatory Strategy

Quality Affairs

Oral Communication

Written Communication

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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