Boston Scientific Product Analyst 

United States, Minnesota, Arden Hills 

31675894

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 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:

• Bachelor’s degree required

Preferred qualifications:

• Relevant industry experience
• 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
• Experience with Medical Devices, cardiology preferred
• Experience in complaint handling
• Experience writing or submitting Medical Device Reports (MDRs)
• Experience working in a Trackwise-based complaint handling system

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.