Hybrid Regulatory Complaint Analyst II - Medical Devices

Boston Scientific; Maple Grove (MN); Hybrid; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific is seeking a Product Complaint Analyst II to review patient complaints within the Urology portfolio and determine regulatory reportability. The role requires clinical data gathering from multiple sources and precise communication of investigations and outcomes to regulators and internal teams.

Hybrid work model with in-office presence required three days per week; relocation assistance is not available.

Qualifications

• Bachelor’s degree or equivalent education.
• 1+ years of experience in medical device complaint processing & reporting.
• Excellent written and verbal communication skills are essential.

Responsibilities

• Review complaint communications and assess complaints for regulatory reportability and potential impacts to patient safety and business operations.
• Apply clinical knowledge related to product usage to evaluate complaints and investigate data from clinical staff, field representatives, internal staff, laboratory results, and other sources.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in development and modification of decision models with product advances to uphold compliance with regulations.
• Write Medical Device Reports (MDRs), Vigilance and other regulatory reports and ensure timely submission to regulators.
• Accurately apply codes to events and review coding and investigations with engineering and other staff as appropriate.
• Compose written communications detailing observations, investigations, and actions to physicians and end users.

Skills

Medical device complaint processing &

Regulatory reporting

Education

Bachelor’s degree or equivalent education

Job description

Boston Scientific is seeking a Product Complaint Analyst II to review patient complaints within the Urology portfolio and determine regulatory reportability. The role requires clinical data gathering from multiple sources and precise communication of investigations and outcomes to regulators and internal teams.

Hybrid work model with in-office presence required three days per week; relocation assistance is not available.