Program Manager, Regulatory Affairs, Maternal Infant Care at GE Healthcare

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Maternal Infant CareIndustries

Requirements

Bachelor's degree in a Scientific, Engineering, Computer Science, or other core Life Science discipline, or a combination of training and experience demonstrating the equivalent
A minimum of 6 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics
A minimum of 5 years’ experience in Regulatory Affairs
A minimum of 5 years’ experience in regulatory agency interactions and regulatory project management
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications
Proven interpersonal skills

Responsibilities

Provides regulatory strategy and direction for the MIC business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally
Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA, EU, NMPA, PMDA, MFDS, CDSCO, etc., as per business’ timelines
Assesses changes in existing products and determines the need for new / revised licenses or registrations
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements
Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements
Provides informal guidance to new team members and explains complex information to others in straightforward situations

Skills

Regulatory Strategy

FDA Submissions

EU Regulations

NMPA

PMDA

MFDS

CDSCO

Premarket Submissions

Post-Market Compliance

Regulatory Affairs

Healthcare Regulations

Global Regulatory Bodies

Advertising Review

Trade Associations

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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