Date: Nov 3, 2018
Location:Arden Hills, MN, US, 55112
Company: Boston Scientific
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 purposeimproving 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 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 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 these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
Write Medical Device Reports (MDRs), MedWatch, 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. Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
What We're Looking For In You:
Bachelor's of Science degree with 5-7 years of relevant experience
Master's of Science degree with 3-5 years of relevant 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
Prior experience with BSC CRM products
Hands-on experience in medical device complaint handling
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 Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 435596
Nearest Major Market: Minneapolis
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