Product Complaint Analyst II
About The Position
About the role: The Product Complaint Analyst II analyzes customer complaints to determine regulatory reportability and collaborates with internal teams, field personnel, and end-use customers to support complaint investigations. This role ensures adherence to Good Manufacturing Practices (GMPs), the Code of Federal Regulations (CFR), and all applicable governmental regulations. You will communicate investigation results through regulatory reports and written correspondence, helping ensure patient safety and product quality. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
Requirements
- Bachelor’s degree.
- Minimum of 2 years of experience in a health care, clinical, technical, scientific, or related field.
Nice To Haves
- Bachelor’s degree in Biology, Health Sciences, Biotechnology, Engineering, or related discipline.
- Experience with TrackWise or other complaint-handling systems.
- Experience preparing and submitting MDR, MedWatch, Vigilance, or similar regulatory reports.
- Experience with SAS or PowerBI is a plus.
- Strong attention to detail and critical thinking skills.
- Excellent written and verbal communication skills.
- Self-motivated, goal-driven, and results-oriented team player.
- Strong time-management and organizational skills.
Responsibilities
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact on patient safety and business operations.
- Apply clinical and technical knowledge related to product application to evaluate complaints.
- Investigate complaints by gathering and analyzing data from clinical staff, field representatives, internal employees, and laboratory analysis.
- Establish regulatory reportability decisions using event investigation tools and decision models.
- Participate in the development and modification of decision models as product technologies and therapies evolve.
- Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring accurate and timely submission to regulatory authorities.
- Apply appropriate event coding to support product performance tracking, collaborating with engineering, laboratory, and other internal stakeholders to review investigation findings.
- Compose written communications summarizing clinical observations, investigation results, product analysis, and corrective actions for internal and external audiences, as appropriate.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
