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Product Complaint Analyst II at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, 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

Good Manufacturing Practices, Complaint Handling, Clinical Knowledge, Data Gathering, Investigation, Regulatory Reportability, Decision Models, Product Performance, Communication Skills, Self-Motivated, Critical Thinking, Time Management, Biology, Health Sciences, Biotechnology, Engineering

Industry

Medical Equipment Manufacturing

Description

Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. 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. Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations. Apply codes to events to facilitate product performance records. Bachelors degree or equivalent education 1+ years of experience in medical device complaint processing & reporting Excellent written and verbal communication skills are essential Self-motivated, goal-driven and results-oriented team player Critical thinking and good time management skills College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred

Responsibilities

The Product Complaint Analyst II is responsible for ensuring adherence to Good Manufacturing Practices and proper complaint handling according to governmental regulations. This includes investigating complaints, gathering data, and establishing regulatory reportability decisions.