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 Complaint Analyst II analyzes customer complaints to determine regulatory reportability and collaborates with internal teams, field personnel, and end-use customers to support complaint investigations. This role ensures adherence to Good Manufacturing Practices (GMPs), the Code of Federal Regulations (CFR), and all applicable governmental regulations. You will communicate investigation results through regulatory reports and written correspondence, helping ensure patient safety and product quality.

 

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:

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact on patient safety and business operations.
• Apply clinical and technical knowledge related to product application to evaluate complaints.
• Investigate complaints by gathering and analyzing data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation tools and decision models.
• Participate in the development and modification of decision models as product technologies and therapies evolve.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring accurate and timely submission to regulatory authorities.
• Apply appropriate event coding to support product performance tracking, collaborating with engineering, laboratory, and other internal stakeholders to review investigation findings.
• Compose written communications summarizing clinical observations, investigation results, product analysis, and corrective actions for internal and external audiences, as appropriate.

 

Required qualifications: 

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

 

Preferred qualifications: 

• Bachelor’s degree in Biology, Health Sciences, Biotechnology, Engineering, or related discipline.
• Experience with TrackWise or other complaint-handling systems.
• Experience preparing and submitting MDR, MedWatch, Vigilance, or similar regulatory reports.
• Experience with SAS or PowerBI is a plus.
• Strong attention to detail and critical thinking skills.
• Excellent written and verbal communication skills.
• Self-motivated, goal-driven, and results-oriented team player.
• Strong time-management and organizational skills.

 

 

 

 

Requisition ID: 620089 

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