Program Manager for Global Compliance (CCN) at GE Healthcare

Wuxi, China

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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 DevicesIndustries

Requirements

Bachelor’s or master’s degree within appropriate Engineering/Science discipline
Excellent verbal and written communication skills in English, ability to communicate across organization levels and to connect with different audiences in a multicultural environment
Program Management experience or Regulatory & Standard work related is preferred
Proven track record of driving projects forward and delivering results without supervision
Decision maker, strong communication, collaboration and leadership skills to work effectively with global cross-functional teams
Clear thinker who can analyze data to establish a direction to proceed in a timely and logical manner
Strong commitment to compliance with relevant regulations and procedures, and demonstrated knowledge or experience in Medical Device development under Quality Management System

Responsibilities

Create an inclusive, positive, and empowering team environment, and foster a culture of compliance and continuous improvement while leading global and cross-functional teams
Balance multiple projects simultaneously and drive clear decisions based on business objectives
Ensure global Anesthesia and Vaporizer products compliance with the latest regulatory and standard requirements
CCN Process Establishment: Establishing the process and Operating Mechanism to manage the CCNs to optimize the global engineering resource and ensure the products compliance to the standard and regulatory changes
CCN Interpretation: Working with Global CCN SME, Safety and Regulatory Engineer (SRE), Product Regulatory Affair (PRA), Quality Assurance (QA) and the relevant Technical Expert to review the CCNs from the countries all over the world to understand the CCN content and change details
CCN Evaluation for Global Products: Leading the CCN review with the global program teams to evaluate the impact to the different segment Anesthesia and Vaporizer products (Premium products in Madison USA, Performance products in Wuxi China, Value products in Bangalore India)
Project Planning and Execution: Developing the project plans for each affected CCN and driving the execution with the help from different segment Program Managers according to the committed timelines and within the CCN compliance due date
Project Reporting and Escalation: Monitoring the project execution and regularly reporting to the key stakeholders, identifying the risks during the project execution and involving leadership team to prioritize the resource and budget when the forward production or New Product Introduction (NPI) is heavily impacted

Skills

Key technologies and capabilities for this role

Program ManagementRegulatory ComplianceRoHSREACHPFASCCNProject PlanningCross-functional LeadershipQuality AssuranceRisk AssessmentGlobal StandardsCybersecurity StandardsEMC StandardsUsability Standards

Questions & Answers

Common questions about this position

What qualifications are required for the Program Manager role?

A Bachelor’s or master’s degree within an appropriate Engineering/Science discipline is required, along with excellent verbal and written communication skills in English to communicate across organization levels.

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 kind of team environment does the company foster?

The role involves creating an inclusive, positive, and empowering team environment while fostering a culture of compliance and continuous improvement, leading global and cross-functional teams.

What skills make a strong candidate for this Program Manager position?

Strong candidates can balance multiple projects, drive clear decisions based on business objectives, lead cross-functional teams, and manage project planning, execution, reporting, and escalation effectively.

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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