Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Maple Grove, Minnesota
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.
About This Role:
The Senior Product Analyst analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. Responsible for adherence to Good Manufacturing Practices (GMPs) and complaint handling per the Code of Federal Register (CFR) and all other international governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
Your Responsibilities Will Include:
* Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
* 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 regulator decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations (domestic & international).
* Author Medical Device Reports (MDRs), Med Watch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
* Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.
* Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
What We re Looking For In You:
* Bachelor s Degree Required and 5-7 years of experience or Master's degree and 3-5 years of experience
* Hands-on experience in medical device complaint handling
* Familiarity with medical device terminology as well as anatomical and physiological terminology is required.
* Must be self-motivated, goal-driven and results-oriented; must be able to perform with limited guidance and direction
* Excellent written and verbal communication skills
* Direct experience in writing and filing Med Watch and Vigilance reports preferred
* Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook); experience with presentation applications such as PowerPoint and/or database applications such as Microsoft Access, and complaint database applications such as Track Wise Quality Management Software, is a plus
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 Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 441754
Nearest Major Market: Minneapolis
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