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
   

 

 

 

Requisition ID: 599633 

Minimum Salary: $ 58200 

Maximum Salary: $ 110500 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global