Posted: Wednesday, November 8, 2017 2:18 AM
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 II
We currently have an exciting opportunity for a Product Analyst to work on our Maple Grove campus and work within the medical device industry to gain an understanding of how medical device technology and our devices interact with patients. In this role, you will analyze customer complaints to determine which are regulatory reportable and coordinate activities with internal, field, and end use customers.
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, report ability, and potential impact to patient safety and business operations.
:Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
:Communicate with internal/external customers to gain insight into each complaint event
:Ensure complaint records, Regulatory reports, and applicable complaint handling documents are compliant with Good Documentation Practices (GDP), global regulatory standards and internal procedures.
:Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition 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 Were Looking For:
:Bachelor's degree with 3:5+ years of relevant experience or equivalent education and related experience
:Proficiency with computer application such as Microsoft Office (Excel, Word, Outlook,)
:Excellent written and verbal communication skills are essential
:Must be self:motivated, goal:driven and results:oriented team player
:Hands:on experience in medical device complaint handling
:Direct experience in writing and filing MedWatch reports
:Familiarity with medical device terminology
:Familiarity with Anatomy/Physiology terminology
:Critical thinking and good time management
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
• Location: Minneapolis / St. paul
• Post ID: 27065057 minneapolis