Hybrid Regulatory Complaint Analyst I

Boston Scientific Corporation; Arden Hills (MN); Hybrid; USD 51,000 - 97,000; Full time

Job summary

Boston Scientific Corporation seeks a Product Complaint Analyst I to analyze customer complaints within the Urology portfolio and determine regulatory reportability. The role coordinates with internal teams, field personnel, and end-users to ensure compliant investigations and timely regulatory submissions.

The position operates in a hybrid model, requiring in-office presence at least three days per week. A bachelor’s degree is required, with preference for candidates experienced in medical

Qualifications

• Bachelor’s degree or equivalent education (required)
• Excellent written and verbal communication skills essential
• Experience in medical device complaint processing is a plus

Responsibilities

• Review complaints for regulatory reportability and impact on patient safety and operations
• Gather data from clinical staff, field reps, internal staff, labs to investigate complaints
• Establish regulatory reportability decisions using investigation models
• Develop and modify decision models with product advances to ensure regulatory compliance
• Write MDRs, Vigilance and other regulatory reports with timely submissions
• Code events accurately; review coding with engineering and labs
• Prepare clear written communications detailing observations and actions for physicians and end-users

Skills

Excellent written communication

Excellent verbal communication

Medical device complaint processing

Education

Bachelor’s degree or equivalent education

College Degree focus in Biology, Health Sciences, Biotechnology or Engineering

Job description

Boston Scientific Corporation seeks a Product Complaint Analyst I to analyze customer complaints within the Urology portfolio and determine regulatory reportability. The role coordinates with internal teams, field personnel, and end-users to ensure compliant investigations and timely regulatory submissions.

The position operates in a hybrid model, requiring in-office presence at least three days per week. A bachelor’s degree is required, with preference for candidates experienced in medical