Product Complaint Analyst II

Boston Scientific•Arden Hills, MN

4d•$59,900 - $113,800•Hybrid

About The Position

The Product Complaint Analyst II analyzes customer complaints to determine regulatory reportability and coordinates activities with internal teams, field personnel and end-use customers. This role is responsible for adherence to good documentation practices (GDPs) and complaint handling requirements under the Code of Federal Regulations (CFR) and other applicable international regulations. The Product Complaint Analyst II communicates event investigation results through regulatory reports and written communications, as appropriate.

Requirements

Bachelor's degree.
Minimum of 2 years' experience in a health care, clinical, technical, scientific or related field.
Ability to manage multiple dashboards and inputs while adapting to rapidly shifting priorities.

Nice To Haves

Knowledge of interventional cardiology medical devices.
Experience with a TrackWise-based complaint handling system.
Experience with MDR and MDV submissions.
Experience evaluating and investigating patient complication and death events.
Medical device industry experience.
Post-market or quality experience.
Strong attention to detail.
Critical-thinking skills.
Excellent written and verbal communication skills.
Self-motivated, goal-driven and results-oriented team player.

Responsibilities

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