Lead Specialist, Product Surveillance, Digital

Job Description Summary

Manages 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.

Additional Information