Regulatory Complaint Analyst II – Medical Devices

Boston Scientific; Irvine (CA); Hybrid; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific in Irvine, CA is seeking a Product Complaint Analyst II to analyze customer complaints for regulatory reportability within the Urology portfolio and coordinate with internal teams. The role requires applying CFR-based procedures, gathering data from clinical staff and labs, and writing regulatory reports.

This is a hybrid role with three days in the office. Ideal candidates have a science/engineering background and strong communication skills; relocation assistance is not

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, as related to product usage, to evaluate complaints. Investigate complaints by gathering data from clinical staff, field representatives, internal employees, laboratory results, and other sources.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Participate in development and modification of these decision models with changes in product advances/therapies to uphold compliant regulations.
• Write Medical Device Reports (MDRs), Vigilance, and other regulatory reports, ensuring timely submission to regulators.
• Accurately apply codes to events and review coding with engineering, laboratory, and internal staff.
• Compose written communications detailing observations, investigations and analyses to physicians and end users.

Skills

Excellent written and verbal communic

Critical thinking

Time management

Education

Bachelor’s degree or equivalent education

Job description

Boston Scientific in Irvine, CA is seeking a Product Complaint Analyst II to analyze customer complaints for regulatory reportability within the Urology portfolio and coordinate with internal teams. The role requires applying CFR-based procedures, gathering data from clinical staff and labs, and writing regulatory reports.

This is a hybrid role with three days in the office. Ideal candidates have a science/engineering background and strong communication skills; relocation assistance is not