F) at GE Healthcare

Bucharest, Bucharest, Romania

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical ImagingIndustries

Requirements

Advanced experience in Regulatory Affairs, ideally within the medical device industry, or advanced experience in product development within the medical device industry
Bachelor’s degree from an accredited university or college, or equivalent relevant experience
Strong analytical, problem-solving, and project management skills
Excellent oral and written communication abilities
Proficiency in English (written and spoken)

Responsibilities

Lead global regulatory projects to secure market authorization and promotional approval for medical devices
Collaborate closely with product development teams, including engineering, marketing, clinical investigations, and regional regulatory experts
Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines
Identify and define product testing and clinical study requirements to support regulatory submissions
Analyze and organize scientific data to demonstrate the safety and efficacy of medical devices
Prepare and submit regulatory documentation to authorities across global markets including the US, Canada, Latin America, Europe, China, and Asia
Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards
Evaluate design changes and determine licensing or registration needs
Review and approve promotional materials to ensure alignment with regulatory claims
Monitor regulatory trends and communicate new requirements to internal teams
Support regulatory inspections and audits as needed

Skills

Key technologies and capabilities for this role

Regulatory AffairsMedical DevicesRegulatory StrategyGlobal Regulatory SubmissionsClinical StudiesProduct DevelopmentComplianceMammography ImagingAI ApplicationsFDAEU MDRProject Management

Questions & Answers

Common questions about this position

What qualifications are required for this Program Manager role?

Candidates need advanced experience in Regulatory Affairs or product development within the medical device industry, a Bachelor’s degree from an accredited university or equivalent relevant experience, strong analytical, problem-solving, and project management skills, excellent oral and written communication abilities, and proficiency in English.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What is the work environment like at GE HealthCare for this role?

This is a global leadership position in a dynamic environment where you lead cross-functional teams and drive regulatory strategies for innovative Mammography imaging products, including AI applications, with direct impact on patient care worldwide.

What experience makes a candidate stand out for this role?

Desired characteristics include experience interacting with global regulatory agencies like FDA, Notified Bodies, and NMPA, knowledge of Quality Management Systems and regulatory compliance frameworks, and proven ability to work independently in a fast-paced, dynamic environment.

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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