Regulatory Affairs Leader Point-of-Care Ultrasound at GE Healthcare

Haifa, HA, Israel

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, UltrasoundIndustries

Requirements

Bachelor's or Master's degree in scientific, technology, or legal discipline
Significant experience with EU CE marking and US FDA 510(k) submissions of medical devices
Where required by law, the Technical Responsible will meet required qualifications in terms of education, certifications, and experience
Ability to communicate effectively in Hebrew and English (both written and oral)
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications

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 (including product testing, clinical data, etc.), product claims, and country regulatory dependencies to ensure optimized sequencing for submissions
Works with a cross-functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch
Assesses changes in existing products and determines the need for new/revised licenses or registrations
Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements
Contributes to writing and editing technical documents
Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions
Understands and applies regulatory requirements and their impacts for submissions
Ensures compliance with pre- and post-market product approval requirements
Supports regulatory inspections as required
Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations
Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager

Skills

Key technologies and capabilities for this role

Regulatory AffairsEU Technical FileFDA 510(k)Quality SystemsGlobal Regulatory ComplianceProduct DevelopmentRegulatory SubmissionsRisk ManagementClinical DataCross-Functional Collaboration

Questions & Answers

Common questions about this position

Is this position remote or does it require being located near a specific site?

Candidates for this role are located near our site in Haifa, Israel. Remote workers will be considered depending on availability of local candidates.

What are the key responsibilities of the Regulatory Affairs Leader?

The role involves providing regulatory input for product development, developing regulatory strategies for submissions, filing US FDA 510(k)s, maintaining EU Technical File sections, and collaborating with global teams to obtain clearances in target markets.

What qualifications are required for this role?

A Bachelor's or Master's degree in scientific, technology, or legal fields is required.

What kind of collaboration is involved in this position?

You will closely collaborate with global Engineering, Supply Chain, Site Manufacturing, and Quality teams in Europe, India, China, Mexico, and US.

What is the salary or compensation for this role?

This information is not specified in the job description.

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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