Product Complaint Analyst I

Product Complaint Analyst I

The Product Complaint Analyst I will be help to analyze customer complaints to determine which are regulatory reportable and coordinates activities with internal, field, and end use customers. The Product Complaint Analyst I will be responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. The Product Complaint Analyst I will communicate event investigation results via regulatory reports and written communications, as appropriate.

In all actions, the Product Complaint Analyst I will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

This role follows a hybrid work model requiring employees to be in our Arden Hills, MN office at least three days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

This role will not provide relocation support or assistance.

Your responsibilities will include:

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
• 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 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.
• Draft 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.

Required qualifications:

• Minimum of a Bachelors degree
• Minimum of less than one year of experience

Preferred qualifications:

• Experience in complaint handling
• Experience writing or submitting Medical Device Reports (MDRs)
• Experience with Medical Devices, Electrophysiology preferred
• Experience working in a Trackwise-based complaint handling system
• Experience with general Microsoft Programs (Excel, Word, Outlook, etc)
• Strong analytical and problem solving skills
• Excellent communication skills
• Strong organizational skills and attention to detail

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.