Senior Engineer, Technical Regulation at GE Healthcare

Wuxi, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical TechnologyIndustries

Requirements

Bachelor’s or Master’s degree in Engineering, Materials Science, Chemistry, or a related field
8+ years of experience in regulatory compliance, product stewardship, or technical engineering roles
Proven experience managing global compliance programs (RoHS, REACH, PFAS, etc.)
Strong knowledge of international environmental and safety regulations
Experience with certification databases, compliance audits, and gap analysis
Familiarity with supplier certification processes and documentation systems
Excellent communication and collaboration skills across global teams
Strong analytical and problem-solving abilities
Self-motivated and capable of independently driving compliance initiatives

Responsibilities

Ensure ARC product compliance with environmental regulations (e.g., RoHS, REACH, PFAS, POPs, F-Gas) across global markets
Maintain close communication with the Global Environmental center team and relevant stakeholders
Continuously assess regulatory impacts on ARC teams and operations
Develop compliance standards for each applicable regulation
Collect supporting evidence and generate compliance documentation based on defined standards
Ensure product compliance prior to market launch or regulatory enforcement deadlines
Respond to environmental regulatory queries during market bidding processes
Support internal and external audits related to environmental compliance
Assist with post-market surveillance, sampling inspections, and corrective actions
Manage certification databases, perform gap analysis, and prepare for audits
Investigate and report on current compliance status using existing documentation
Work with SQE and other teams to close compliance gaps, including supplier evidence collection
Coordinate across modalities to ensure consistent and traceable documentation systems
Gain access to necessary tools and systems to report compliance status
Develop and maintain standard work procedures for engineering compliance management

Skills

Key technologies and capabilities for this role

RoHSREACHPFASPOPsF-GasRegulatory ComplianceAudit ManagementGap AnalysisCompliance DocumentationPost-Market SurveillanceSupplier ManagementCross-Functional Collaboration

Questions & Answers

Common questions about this position

What qualifications and experience are required for this Senior Engineer role?

A Bachelor’s or Master’s degree in Engineering, Materials Science, Chemistry, or a related field is required, along with 8+ years of experience in regulatory compliance, product stewardship, or technical engineering roles, and proven experience managing global compliance programs like RoHS and REACH.

What technical skills are needed for this position?

Candidates need strong knowledge of international environmental and safety regulations, experience with certification databases, compliance audits, and gap analysis, plus familiarity with supplier certification processes and documentation systems.

What is the salary or compensation for this role?

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 does GE HealthCare's company culture emphasize?

GE HealthCare emphasizes creating a world where healthcare has no limits, unlocking ambition, turning ideas into world-changing realities, and an organization where every voice makes a difference to build a healthier world.

What makes a strong candidate for this Senior Engineer position?

A strong candidate has 8+ years in regulatory compliance with proven global program management for regulations like RoHS, REACH, and PFAS, plus expertise in audits, gap analysis, and cross-functional collaboration.

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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