Boston Scientific Product Complaint Analyst 

United States, Minnesota 

74323417

The Product Complaint Analyst I will work in a fast-paced environment to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable. Will be responsible for adherence to Good Documentation Practices (GDP) and required processing of complaint handling records per the Code of Federal Regulations (21CFR) and International regulatory agencies. In addition, will initiate follow up with field sales representatives, end use customers and complaint investigation site to obtained additional event details, as applicable. Communicates event investigation results via regulatory reports and written communications, as appropriate. Products within scope include but are not limited to men’s prosthetic urology, prostate health, and surgical lasers.

Your responsibilities will include:

• Dispositioning of events that meet complaint criteria
• Accurately performs regulatory assessment
• Files regulatory reports within country respective timelines.
• Follows up with customer, physician and sales representative for additional information as applicable.
• Coordinate and collaborates with the complaint investigation site for on time completion of event investigations in order to meet regulatory report filing due dates.
• Issues customer response letters, closes complaint files and documents objective evidence for audit readiness.
• Follows implemented policies and procedures to ensure compliance with appropriate statues and regulations
• Participates in department system improvement projects while able to manage assigned work to achieve Urology monthly metric objectives.

Required qualifications:

• Bachelor’s degree
• Minimum of 2 years of related work experience

Preferred qualifications:

• Strong organization and execution skills required, as well as a demonstrated ability to confidently drive project completion
• Demonstrated ability to motivate, lead, make recommendations, and work in cross-functional teams
• Effectively able to multitask and prioritizes work in a fast paste changing environment
• Strong interpersonal, communication, presentation and writing skills
• Experience working within medical device industry and familiarity with 21 CFR 820, EU MDR, and ISO 13485 regulations
• Quality Systems background –key quality system regulations (21 CFR 820 and ISO 13485 at a minimum)
• Basic understanding of complaints or complaint handling process
• Proficient in Microsoft Power Point, Excel, Outlook, Microsoft Word and Teams
• eMDR and EUMDR Regulatory filing experience

Maximum Salary: $ 94000

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.

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.