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Product Complaint Analyst III at Boston Scientific Corporation Malaysia
Arden Hills, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

19 Jan, 26

Salary

0.0

Posted On

21 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good Manufacturing Practices, Complaint Handling, Clinical Knowledge, Data Gathering, Regulatory Reportability, Event Investigation, Regulatory Decision Models, Product Performance Records, Critical Thinking, Time Management, SAS, PowerBI, TrackWise, Scientific Literature Review, Medical Device Complaint Processing, Communication Skills

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 Minimum of 5 years of experience in medical device complaint processing and reporting Self-motivated, goal-driven and results-oriented team player Excellent written and verbal communication skills Ability to apply critical thinking Excellent time management College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred Experience with SAS, PowerBI, or TrackWise applications Experience reviewing scientific literature
Responsibilities
The Product Complaint Analyst III is responsible for ensuring adherence to Good Manufacturing Practices and proper complaint handling according to governmental regulations. This includes investigating complaints, establishing regulatory reportability decisions, and participating in the development of decision models.