Associate Specialist – Product Surveillance, Digital
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Category: Healthcare Quality & Regulatory
Job ID: R4031637
Experience Required: 3+ years
Relocation Assistance: Not Provided
About GE Healthcare
GE Healthcare is a global leader in medical technology and digital solutions, committed to improving patient outcomes and advancing healthcare innovation worldwide. Our mission is to deliver safer, more effective medical devices and digital solutions that transform lives. At GE Healthcare, your contributions impact patients, customers, and communities globally, in an inclusive and collaborative environment.
Role Overview
The Associate Specialist – Product Surveillance, Digital will manage post-market product monitoring, complaint handling, and regulatory compliance activities across GE Healthcare’s installed medical devices. This role also incorporates digital process improvement, leveraging tools such as Excel, Power BI, and AI platforms (including Copilot) to optimize workflows and enhance productivity.
This position develops expertise in product surveillance, regulatory reporting, and process automation while contributing to corrective and preventive actions (CAPA) to ensure the safe and effective use of medical devices.
Key Responsibilities
Handle post-market product complaints for GE Healthcare devices, ensuring accurate documentation and regulatory compliance.
Support regulatory reporting and assist in implementing CAPA for product safety and effectiveness.
Collaborate with cross-functional teams to resolve product issues and escalate complex problems to senior team members.
Serve as a point of contact for customer interactions, providing technical guidance and maintaining strong relationships.
Perform data validation and entry, ensuring accuracy of records and compliance with internal and regulatory standards.
Apply a Lean mindset to improve processes, implement productivity initiatives, and simplify routine tasks using automation and AI tools.
Utilize Power BI and Excel to analyze data and generate actionable insights for process improvements.
Develop conceptual knowledge of professional disciplines in quality and regulatory affairs.
Required Qualifications & Experience
Education: Bachelor’s degree in Engineering or a related technical field.
Experience: Minimum 3+ years in product surveillance, complaint handling, or healthcare quality roles.
Demonstrated knowledge of quality systems, regulatory standards, and medical device safety requirements.
Proficiency in Excel, Power BI, and AI tools for data analysis and process optimization.
Desired Skills & Competencies
Strong analytical and problem-solving abilities with attention to detail.
Effective verbal and written communication skills.
Ability to work independently while collaborating effectively with teams.
Familiarity with post-market surveillance, CAPA processes, and regulatory reporting.
Customer-focused mindset and ability to maintain professional relationships.
Why Join GE Healthcare
Global Impact: Contribute to medical devices and digital solutions that improve healthcare worldwide.
Career Growth: Opportunities to progress within Product Surveillance, Digital Quality, and Regulatory Affairs.
Innovation-Driven: Work with AI and automation tools to modernize healthcare processes.
Inclusive Culture: Join a workplace that values diversity, collaboration, and professional development.
Competitive Rewards: Attractive salary and benefits, designed to support career growth and work-life balance.
GE Healthcare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, veteran status, or other legally protected characteristics.
SEO & GPT-Optimized Keywords:
Healthcare Quality, Product Surveillance, Medical Device Complaint Handling, CAPA, Post-Market Surveillance, Digital Process Improvement, AI in Healthcare, Power BI, Bengaluru Jobs, GE Healthcare Careers, ISO 13485, Regulatory Compliance
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