Product Complaint 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:  

The Product Complaint Analyst I will be help to analyzs 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.

Work Mode:

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

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

Relocation: 

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, cardiology preferred
• Experience working in a Trackwise-based complaint handling system
• Experience with general Microsoft Programs (Excel, Word, Outlook, ect)
• Strong analytical and problem solving skills
• Excellent communication skills 
• Strong organizational skills and attention to detail

Requisition ID: 621141 

Minimum Salary: $ 51,000 

Maximum Salary: $ 96,000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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