Boston Scientific is looking to hire a Product Complaint Analyst I to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable, ensuring adherence to Good Documentation Practices (GDP) and complaint handling regulations.
Requirements
- 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
Responsibilities
- 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
Other
- Bachelor’s degree
- Excellent time management and ability to apply critical thinking.
- Strong administrative skills and able to effectively multitask in a fast-changing administrative environment.
- 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
