GE HealthCare has announced a new opportunity for experienced healthcare and medical device professionals in Bengaluru. The company is hiring for the position of Lead Specialist, Product Surveillance, Digital, with a focus on medical device complaint handling, post-market surveillance, regulatory reporting, patient safety, root cause investigation, and CAPA.
This GE HealthCare Bengaluru job is particularly relevant for professionals with experience in Medical Device Quality, Regulatory Affairs, Product Surveillance, Engineering, Complaint Handling, or Post-Market Surveillance. Candidates should have at least 6 years of experience in the healthcare domain or medical device industry.
The position also seeks professionals familiar with digital healthcare technologies such as PACS, RIS, Enterprise Archive, Universal Viewer, HL7, and DICOM.
GE HealthCare Job Details
| Particular | Details |
|---|---|
| Company | GE HealthCare |
| Position | Lead Specialist, Product Surveillance, Digital |
| Job ID | R4045273 |
| Location | Bengaluru, Karnataka |
| Employment Type | Full-Time |
| Experience Required | Minimum 6 Years |
| Preferred Product Surveillance Experience | 3+ Years |
| Industry | Healthcare / Medical Devices |
| Functional Area | Product Surveillance / Quality / Regulatory |
| Relocation Assistance | No |
About the Role
As a Lead Specialist – Product Surveillance, Digital, the selected professional will manage complaint-handling activities and support important Quality and Regulatory functions related to GE HealthCare products.
The role involves applying post-market product surveillance expertise to investigate complaints, assess product and patient safety issues, support regulatory reporting, and contribute to appropriate corrective and preventive actions.
Although this is a lead-level position, the job description indicates that it is primarily an individual contributor role with responsibility for providing informal guidance to newer team members.
Key Responsibilities
The Lead Specialist, Product Surveillance will be responsible for:
- Managing post-market product surveillance and complaint-handling activities for GE HealthCare products.
- Supporting regulatory reporting activities associated with product complaints and safety issues.
- Contributing to appropriate Corrective and Preventive Actions (CAPA) to ensure safe and effective product use.
- Applying previous experience and technical expertise to execute functional policies and strategies.
- Investigating complex product, quality, and safety-related problems using technical and analytical judgment.
- Working with colleagues and cross-functional business teams on design, coordination, quality, and regulatory activities.
- Providing informal guidance and technical support to newer team members.
- Explaining complex technical or regulatory information clearly to relevant stakeholders.
- Supporting projects, processes, and procedures within the product surveillance function.
- Using multiple internal information sources to evaluate problems and support decision-making.
- Exercising professional judgment while operating within established functional practices and procedures.
Required Qualifications
Candidates applying for this GE HealthCare Product Surveillance job in Bengaluru should meet the following requirements:
- Minimum 6 years of experience in the healthcare domain or medical device industry.
- Relevant experience may come from Quality, Regulatory, Engineering, or related medical device functions.
- Knowledge level comparable to a Bachelor’s degree from an accredited university or college.
- Strong technical and analytical problem-solving capabilities.
- Ability to exercise professional judgment while handling quality and product surveillance activities.
Important: The official job description does not specify a particular Bachelor’s degree discipline. Candidates should assess whether their education and professional experience provide the healthcare, medical device, quality, regulatory, or engineering knowledge required for the position.
Preferred Skills and Experience
GE HealthCare lists the following as desired characteristics:
- 3+ years of Product Surveillance experience.
- Hands-on experience or in-depth knowledge of healthcare digital products.
- Knowledge of PACS (Picture Archiving and Communication System).
- Knowledge of RIS (Radiology Information System).
- Experience with Enterprise Archive solutions.
- Familiarity with Universal Viewer and zero-footprint viewers.
- Knowledge of healthcare interoperability standards including HL7 and DICOM.
- Understanding of ISO 13485.
- Knowledge of 21 CFR Part 803, 806 and 820.
- Understanding of MDD and MDR requirements.
- Medical device and patient safety knowledge.
- Experience conducting root cause investigations.
- Practical experience with CAPA.
- Complaint trending knowledge.
- Cross-functional and complex problem-solving experience.
- Strong interpersonal, organizational, communication, and influencing skills.
Who Should Apply?
This opportunity is best suited to experienced professionals currently working in areas such as:
Medical Device Product Surveillance, Post-Market Surveillance, Complaint Handling, Medical Device Quality Assurance, Regulatory Affairs, Quality Engineering, CAPA, Vigilance, Patient Safety, or Digital Healthcare Quality.
Candidates with experience involving medical imaging or healthcare IT systems such as PACS, RIS, HL7 and DICOM may have a particularly relevant profile for this position.
This is not a fresher-level position, as GE HealthCare specifically requires a minimum of six years of relevant healthcare or medical device industry experience.
Why Consider This Opportunity?
Professionals joining this function may gain exposure to several important areas of the medical device lifecycle, including:
- Global medical device product surveillance
- Complaint investigation and handling
- Medical device regulatory reporting
- Patient and product safety
- Root cause analysis
- CAPA processes
- Digital healthcare products
- Medical imaging technologies
- Quality and regulatory compliance
- Cross-functional problem-solving
GE HealthCare operates across medical technology, intelligent devices, digital healthcare solutions, and patient-care technologies, making this opportunity particularly relevant for experienced professionals seeking to develop further expertise in medical device post-market surveillance.
Salary Estimate
GE HealthCare has not disclosed the salary for this vacancy in the provided job posting.
For structured-data purposes only, an estimated Bengaluru market range for a lead-level medical device Product Surveillance/Quality/Regulatory position could be approximately ₹15,00,000 to ₹25,00,000 per year.
Note: This is an editorial market estimate and not an officially disclosed GE HealthCare salary. Actual compensation may vary based on experience, technical expertise, existing compensation, internal pay bands, and the final offer.
How to Apply
