Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Marlborough, Massachusetts
Additional Locations: (n/a)
Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we re solving some of the most important healthcare industry challenges. Together, we re one global team committed to making a difference in people s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life s work.
Product Analyst I
About the role:
Provides technical, reporting and analytical support expertise in reviewing of product quality complaints, serving as primary contact. Monitors complaint information and provides suggestions to appropriate company authorities as to where improvement opportunities exist based upon patterns and related analyses. Provides technical expertise to optimize complaint analysis strategies and systems. Monitors systems and data to facilitate the appropriate and timely handling of all product complaints per the company s compliant handling procedure. Ensures compliance with applicable regulations, company policies and procedures.
Your responsibilities include:
* Analyze complaint data for all internal and external customers.
* Manage and oversee trend analysis performed on a routine basis and review for any patterns.
* Interact with the product analysts, engineers and unit managers regarding complaint analysis.
* Prepare presentational material on a variety of complaint data.
* Completes MDR/MDV assessments for all assigned products
* Accountable for managing thorough and accurate complaint records, as well as timely closure of complaint files
* Ensure complaint records, Regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP)
* Complete mandatory training by established due dates
* Maintain accurate and current training records at all times
* Partner with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports for returned product.
* Professional contact with customers to gain insight into each complaint event
* Prepare and submit Regulatory reports within the mandated timelines
* Review and approve assessments/reassessments/MDR/MDVs as required
What we re looking for:
* 4 year college degree
* Familiarity with medical device terminology as well as anatomical and physiological terminology
* Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, and Outlook)
* Excellent written and verbal communication skills are essential
* Must be self-motivated, goal-driven and results-oriented team player
* Critical thinking and good time management skills
* College Degree focus in Biology or Biotechnology preferred
* Hands-on experience in medical device complaint handling preferred
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you re looking to truly make a difference to people both around the world and around the corner, there s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer
Requisition ID: 413769
Nearest Major Market: Boston
Job Segment: Product Manager, Medical, Biotech, Physiology, Law, Operations, Science, Healthcare, Legal