Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Valencia, California
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.
About the role:
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 proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicates event investigation results via regulatory reports and written communications, as appropriate.
Your responsibilities include:
* Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations using established decision models and internal processes.
* Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis
* Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
* Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmition to the appropriate regulatory authorities.
* Apply codes to events to facilitate product performance trending. Review coding and investigations with engineering, laboratory, and other internal staff.
* Draft 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:
* Bachelor s degree or higher from an accredited institution
* Minimum of 6 months experience in complaint handling and MDR filing in medical device or pharma industry
* Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, Outlook, etc.)
* Bachelor s degree in nursing, engineering, biology, physiology, or related
* Excellent verbal and written communication skills
* Experience with medical terminology or medical products
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: 417086
Nearest Major Market: Los Angeles
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