Boston Scientific Product Complaint Analyst II 

United States, Massachusetts, Marlborough 

389363036

Your responsibilities will include:

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Author Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.

Required qualifications:

• Bachelors degree
• Minimum of 1 year of related experience

Preferred qualifications:

• Previous Complaint Handling experience
• Knowledge of medical devices and associated regulations
• Post market surveillance experience or knowledge.