Product Complaint Analyst II

Product Complaint Analyst II

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

About the role: The Product Analyst II analyzes Customer Complaints to determine which are regulatory reportable and coordinates activities with internal, field and end-use Customers. He/she/they is responsible for adherence to Good Documentation Practices (GDPs) and Complaint Handling per the Code of Federal Register (CFR) and all other international governmental regulations. He/she/they will communicate event investigation results via regulatory reports and written communications, as appropriate.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Apply policies and procedures to comply with FDA and OUS regulations
• Evaluate incoming information for Medical Device Reporting and Vigilance reporting eligibility
• Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (MDVs)
• Interface and collaborate with internal and external contacts to collect complaint information efficiently
• Complete continuous compliance training in a timely manner
• Maintain awareness of new products, government regulations, and requirements
• Perform other duties as assigned

Required qualifications:

• Bachelor's degree
• Minimum of 2 years of experience in a health care, clinical, technical, scientific, and/or related field

Preferred qualifications:

• Knowledge of Electrophysiology or ablation Interventional Cardiology medical devices
• Experience with TrackWise-based complaint handling system
• Submissions of MDRs and MDVs
• Experience evaluating and investigation patient complication/death events
• Medical device industry experience
• Post market/Quality
• Attention to detail
• Critical thinking skills
• Excellent written and verbal communication skills
• Self-motivated, goal-driven and results-oriented team player

Refer to ID 85071989 when applying