Lead Specialist, Product Surveillance, Digital

GE Healthcare Healthcare Quality & Regulatory

Qualité

Mid-Career

R4045273

Aide à la réinstallation No

Bengaluru, Karnātaka, Inde, 560066

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Summary

Gère les activités de traitement des réclamations et prend en charge les zones clés de qualité et de réglementation pour garantir des produits sûrs et efficaces dans la base d'installation de GE HealthCare Healthcare. Compréhension approfondie des principaux facteurs opérationnels ; utilise cette compréhension pour accomplir son propre travail. Compréhension approfondie de la manière dont le travail de sa propre équipe s'intègre aux autres équipes et contribue à son domaine.

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 current 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.

Additional Information

Relocation Assistance Provided: No

📌 Lead Specialist, Product Surveillance, Digital (India)
🏢 GE Healthcare
📍 India