Product Analyst I

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

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.

 

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 

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

 

Requisition ID: 587646

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.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we