Medical Device Complaint Specialist

Job title: Medical Device Complaint Specialist

About the Role

Join the medical device complaint management team supporting Boston Scientific via a Wipro engagement. This role focuses on receipt and processing of medical device complaints received through calls, faxes, and emails, serving as the primary point of contact and ensuring timely, compliant handling from receipt to closure. You will enter data in GCMS-TW, manage SAP return authorizations, and collaborate with cross-functional teams while maintaining confidentiality and regulatory compliance.

What You'll Do

• Provide expertise in receipt and processing of medical device complaints via incoming calls, faxes, and emails, serving as the primary point of contact
• Accurately enter complaint information into GCMS-TW in a timely manner and in accordance with the company’s complaint policy and procedures
• Create, maintain, and adjust all return authorizations within SAP for product complaints and field actions and create replacement orders as required
• Respond to inquiries and assist customers and sales representatives regarding Boston Scientific’s complaint and returns policies
• Responsible for the complaint handling process from complaint receipt to record closure; ensure timely processing of complaints
• U.S. customer Complaint communications
• Complete Good Faith Efforts for outcome/result of an Adverse Event and/or complaint sample return
• Maintain As Reported Codes and Rationale Codes
• Review field service records for complaints
• Collaborate with Complaint Investigation Sites, Medical Sciences, Safety Surveillance, Marketing, and Regulatory
• Help with complaint data collection for PIRs
• Ensure that all company information including customer information is kept confidential and secure
• Maintain and follow proper compliance to quality system regulations
• Establish and maintain complete complaint files and databases for all customer complaints, according to complaint, FDA, and international regulatory and complaint requirements related to the complaint system process

What We're Looking For

• Experience in receipt and processing of medical device complaints via calls, faxes, and emails; primary point of contact
• Proficiency with GCMS-TW complaint handling system and SAP for return authorizations
• Knowledge of FDA 21 CFR Part 820 and regulatory compliance requirements
• Strong written and verbal communication skills and customer service orientation
• Ability to handle confidential information securely and maintain data integrity
• Detail-oriented with strong data entry and documentation skills
• Ability to collaborate with cross-functional teams
• Experience with PIR data collection and complaint data management