Senior Product Complaint Analyst — Quality & Regulatory Lead

Boston Scientific; Houston (TX); Hybrid; USD 72,000 - 136,000; Full time

Job summary

Boston Scientific is seeking a Senior Product Complaint Analyst to join our Cardiac Diagnostics Complaint Management Team. You will evaluate and investigate customer complaints, prepare MDRs/MDVs, and support post-market surveillance across global markets, ensuring timely, compliant reporting.

In this hybrid role, you will collaborate with cross-functional partners, maintain GMP adherence, and drive continuous process improvements while delivering clear communications to leadership.

Qualifications

• Associate’s or Bachelor’s degree in a scientific/technical field.
• Minimum 5 years in complaint handling or post-market surveillance in medical devices.
• Experience with FDA/ISO regulations and MS Office.

Responsibilities

• Review and investigate customer complaints to determine reportability and impact.
• Prepare MDRs/MDVs submissions and post-market surveillance activities.
• Collaborate cross-functionally with engineering and QA on investigations.
• Support audits, CAPA and quality system processes.
• Provide clear written communications of investigations and corrective actions.

Skills

Complaint handling

Regulatory knowledge

Analytical problem solving

Communication skills

Education

Bachelor's or Associate degree in science/tech

Tools

Microsoft Office

Job description

Boston Scientific is seeking a Senior Product Complaint Analyst to join our Cardiac Diagnostics Complaint Management Team. You will evaluate and investigate customer complaints, prepare MDRs/MDVs, and support post-market surveillance across global markets, ensuring timely, compliant reporting.

In this hybrid role, you will collaborate with cross-functional partners, maintain GMP adherence, and drive continuous process improvements while delivering clear communications to leadership.