The Role
Manages post-market product surveillance and complaint handling for GE Healthcare digital medical devices. Supports regulatory reporting, corrective and preventive actions, root-cause investigations, compliant trending, and patient safety. Requires collaboration across Quality, Regulatory, Engineering, and other teams while applying medical device regulations, digital healthcare product knowledge, and analytical problem-solving.
Summary Generated by Built In
Job Description SummaryManages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.Job Description
Roles and Responsibilities
- GEHC ONLY Uses skills in post market product surveillance to handle complaints and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare (GEHC) products.
- Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
- A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
- Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
- Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
Required Qualifications
- Minimum of 6 years of experience in the HealthCare Domain / Medical Device industry (Quality, or Regulatory, Engineering, role).
- Knowledge level is comparable to a Bachelor's degree from an accredited university or college.
Desired Characteristics
- 3+ years of experience in Product Surveillance.
- Hands-on experience with, or In depth / applied knowledge of, Healthcare Digital products such as PACS, RIS, Enterprise Archive, Universal Viewer, and zero-footprint viewers, along with interoperability standards such as HL7 and DICOM.
- Demonstrated knowledge of ISO 13485, 21CFR part 803, 806, 820, MDD/MDR
- Medical device and patient safety knowledge.
- Root cause investigation and CAPA experience.
- Compliant trending knowledge.
- Cross-functional complex problem-solving experience.
- Strong interpersonal, organizational, and influencing skills.
- Embodies GE HealthCare Operating Principles.
Relocation Assistance Provided: No
Skills Required
- Minimum 6 years of experience in the healthcare domain or medical device industry, particularly in Quality, Regulatory, or Engineering roles.
- Knowledge level comparable to a bachelor's degree from an accredited university or college.
- 3+ years of experience in product surveillance.
- Hands-on or in-depth applied knowledge of healthcare digital products such as PACS, RIS, Enterprise Archive, Universal Viewer, and zero-footprint viewers.
- Knowledge of interoperability standards including HL7 and DICOM.
- Knowledge of ISO 13485, 21 CFR Parts 803, 806, and 820, and MDD/MDR.
- Medical device and patient safety knowledge.
- Root-cause investigation and CAPA experience.
- Compliant trending knowledge.
- Cross-functional complex problem-solving experience.
- Strong interpersonal, organizational, and influencing skills.
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
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The Company
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
