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Product Complaint Analyst II at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jan, 26

Salary

0.0

Posted On

25 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Complaint Handling, Medical Devices, Regulatory Compliance, Post Market Surveillance, Clinical Knowledge, Data Gathering, Event Investigation, Regulatory Decision Models, Laboratory Analysis

Industry

Medical Equipment Manufacturing

Description

Provides technical expertise to optimize complaint analysis strategies and systems. Ensures compliance with applicable regulations, company policies and procedures. Your responsibilities will include: 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. Apply codes to events to facilitate product performance records. Bachelors degree Minimum of 1 year of related experience Previous Complaint Handling experience Knowledge of medical devices and associated regulations Post market surveillance experience or knowledge.

Responsibilities

The Product Complaint Analyst II provides technical expertise to optimize complaint analysis strategies and systems. Responsibilities include investigating complaints and establishing regulatory reportability decisions.