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Analyst, Sr Product

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

Hiring Manager: Mark A Mischke
Recruiter: Spencer Gregory Hale

 

Sr. Product Analyst

 

About The Role:
The Arden Hills Complaints Handling Team has developed a model for efficiently and compliantly processing complaints that has led to an admirable record of results.  The management approach is based on a team centered model where each employee has a voice in how we operate and optimize current processes. This position is in a supportive environment of providing employees with opportunities to learn and enhance skill sets that are aligned with future career direction.

 

Analyzes customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers.  He/she/they is responsible for adherence to Good Manufacturing Practices (GMPs) and complaint handling per the Code of Federal Register (CFR) and all other international governmental regulations.  He/she/they 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.
  • 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 report ability 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 (domestic and international).
  • Write Medical Device Reports (MDRs), Med Watch, 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.  Communications include determination/eligibility for warranty credit or unreimbursed medical payments.

 

What We’re Looking For:

Basic Qualifications

  • 5 - 7 years relevant experience with bachelor’s degree
  • 3 - 6 years relevant experience with master’s degree
  • Medical Device industry experience

 

Preferred Qualifications

  • Prior experience with BSC CRM or similar products
  • Direct experience in writing and filing Med Watch and Vigilance reports
  • Strong planning/organizational skills
  • Excellent interpersonal and problem-solving skills
  • 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 Global Complaint Management System - Track Wise, is a plus.
  • Excellent written and verbal communication skills
  • Must be self-motivated, goal-driven and results-oriented; must be able to perform with limited guidance and direction

 

Requisition ID: 553799


Nearest Major Market: Minneapolis

Job Segment: Compliance, Law, Laboratory, Medical Device, Quality Assurance, Legal, Science, Healthcare, Technology

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