Regulatory Affairs Manager at GE Healthcare

Tokyo, Tokyo, Japan

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical DevicesIndustries

Requirements

Minimum 5 years of experience in Regulatory Affairs for pharmaceuticals and/or medical devices
Fluent Japanese (native level)
Business-level English proficiency
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint, Outlook)

Responsibilities

Lead regulatory submissions and approvals for pharmaceuticals and medical devices
Manage communications and consultations with regulatory authorities
Oversee updates to product labeling and packaging
Review promotional materials to ensure regulatory compliance
Provide regulatory insights and guidance to internal teams and global counterparts
Build and maintain strong relationships with regulatory agencies and suppliers

Skills

Key technologies and capabilities for this role

Regulatory AffairsPharmaceuticalsMedical DevicesRegulatory SubmissionsRegulatory ComplianceJapanese Regulatory AuthoritiesProduct LabelingPromotional Materials ReviewCross-functional CollaborationProject ManagementMicrosoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft Outlook

Questions & Answers

Common questions about this position

What experience is required for the Regulatory Affairs Manager role?

Minimum 5 years of experience in Regulatory Affairs for pharmaceuticals and/or medical devices is required, along with fluent Japanese (native level) and business-level English proficiency, plus basic PC skills in Microsoft Office tools (Excel, Word, PowerPoint, Outlook). Nice-to-have qualifications include experience in cross-functional and cross-regional teams, strong communication skills, adaptability, and project management experience.

Is relocation assistance provided for this position?

No relocation assistance is provided.

What career growth opportunities are available in this role?

The role offers global exposure through collaboration with international teams, impactful work on life-changing healthcare products, and opportunities to leverage expertise in Regulatory Affairs for growth into leadership roles within a global organization.

What is the salary or compensation for this position?

This information is not specified in the job description.

What makes a strong candidate for this Regulatory Affairs Manager position?

A strong candidate will have the minimum 5 years of regulatory affairs experience in pharmaceuticals/medical devices, native-level Japanese and business-level English, plus nice-to-haves like cross-functional/cross-regional team experience, strong communication, adaptability, and project management skills to excel in global collaboration and regulatory leadership.

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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