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Product Complaint Analyst II at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

0.0

Posted On

20 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Good Manufacturing Practices, Complaint Handling, Clinical Knowledge, Data Gathering, Regulatory Reportability, Event Investigation, Regulatory Decision Models, Product Performance Records, TrackWise, MDR Submissions, MDV Submissions, Patient Complication Evaluation, Medical Device Industry, Post Market Quality, Attention to Detail, Critical Thinking

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. Bachelor's degree Minimum of 2 years of experience in a health care, clinical, technical, scientific, and/or related field Knowledge of Left Atrial Appendage Closure medical devices Experience with TrackWise -based complaint handling system Submissions of MDRs and MDVs Experience evaluating and investigation patient complication/death events Medical device industry experience Post market/Quality Attention to detail Critical thinking skills Excellent written and verbal communication skills self-motivated, goal-driven and results-oriented team player

Responsibilities

The Product Complaint Analyst II is responsible for ensuring adherence to Good Manufacturing Practices and proper complaint handling according to regulations. This includes investigating complaints, establishing regulatory reportability decisions, and participating in the development of decision models.