Boston Scientific Product Complaint Analyst II 

United States, Minnesota 

113317473

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
  

Maximum Salary: $ 110500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.