Product Complaint Analyst I

Boston Scientific - Arden Hills, MN

Full-time - Entry Level

Arden Hills, MN

Miscellaneous Manufacturing

About the position

The Product Complaint Analyst I at Boston Scientific plays a crucial role in analyzing customer complaints related to urology products, ensuring compliance with regulatory standards, and coordinating with various stakeholders. This position requires a blend of clinical knowledge and regulatory expertise to assess complaints, determine reportability, and communicate findings effectively. The analyst will work in a fast-paced environment, contributing to the safety and quality of medical devices while supporting the company's mission to improve patient health.

Responsibilities

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge to evaluate identified complaints related to product application.
• Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in development and modification of decision models with changes in product advances/therapies.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to regulatory authorities.
• Apply codes to events to facilitate product performance records and review coding and investigations with engineering and laboratory staff.
• Compose written communications detailing clinical observations, investigations, and corrective actions to physicians and end-use customers.

Requirements

• University degree or equivalent qualification
• 1+ years of experience in medical device complaint handling
• Fluent in Spanish

Nice-to-haves

• Excellent written and verbal communication skills
• Self-motivated, goal-driven, and results-oriented team player
• Critical thinking and good time management skills
• College Degree focus in Biology, Health Sciences, Biotechnology or Engineering preferred

Benefits

• Access to the latest tools and training
• Opportunities for career advancement
• Supportive work environment for skill development