Associate Specialist – Product Surveillance
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Category: Healthcare Quality & Regulatory
Job ID: R4032775
Experience Required: 3+ years (including minimum 18 months in complaint handling)
Relocation Assistance: Not Provided
About GE Healthcare
GE Healthcare is a global leader in medical technology and digital solutions, dedicated to creating a world where healthcare has no limits. We innovate to improve patient outcomes worldwide by delivering advanced medical devices, imaging solutions, and regulatory-compliant quality systems. At GE Healthcare, your work drives global impact, and every contribution builds a healthier world.
Role Overview
The Associate Specialist – Product Surveillance will focus on post-market product monitoring, complaint handling, and regulatory compliance to ensure the safety and effectiveness of GE Healthcare products, including CT, PET, Nuclear Medicine, Mammography, Vascular, and other imaging systems.
This role develops expertise in product surveillance and regulatory reporting, applying industry best practices to resolve issues, support corrective and preventive actions (CAPA), and maintain high standards of customer satisfaction.
Key Responsibilities
Manage complaint handling activities for installed medical devices, ensuring timely and accurate documentation.
Support regulatory reporting and implement corrective and preventive actions (CAPA) to maintain product safety and compliance.
Collaborate with cross-functional teams to resolve product-related issues within defined procedures.
Build strong relationships with internal and external stakeholders, including customers, providing technical guidance and support.
Perform data entry and validation for complaint records, ensuring accuracy and adherence to compliance standards.
Develop knowledge of professional and technical disciplines, contributing to continuous improvement in product surveillance processes.
Escalate issues outside of established parameters to senior team members or leadership for resolution.
Required Qualifications & Experience
Education: Bachelor’s degree in Engineering or related technical field.
Experience: Minimum 3+ years in relevant technologies, including at least 18 months in medical device complaint handling or product surveillance.
Strong understanding of quality systems, regulatory requirements, and medical device safety standards.
Basic proficiency in data management and complaint tracking systems.
Desired Skills & Competencies
Ability to analyze and resolve technical issues with attention to detail.
Excellent communication skills, both verbal and written, with the ability to interact with customers and internal teams.
Strong problem-solving and decision-making capabilities within defined guidelines.
Ability to work independently while contributing effectively in a team environment.
Familiarity with regulatory frameworks such as ISO 13485, FDA 21 CFR Part 820, and medical device post-market requirements is a plus.
Why Join GE Healthcare
Global Exposure: Work with cutting-edge medical devices and contribute to patient care worldwide.
Career Growth: Opportunities to advance within Product Surveillance, Quality Assurance, and Regulatory Affairs.
Inclusive Culture: Join a workplace that values diversity, collaboration, and innovation.
Comprehensive Benefits: Competitive salary, flexible work environment, and career development opportunities.
GE Healthcare is an Equal Opportunity Employer, committed to diversity, equity, and inclusion. 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 Keywords Optimized:
Healthcare Quality, Product Surveillance, Medical Device Complaint Handling, CAPA, Post-Market Surveillance, Regulatory Compliance, Bengaluru Jobs, GE Healthcare Careers, ISO 13485, FDA 21 CFR, Medical Device Safety, Remote Opportunities in India
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