Regulatory Complaints Analyst - Medical Devices (Hybrid)

Boston Scientific; Arden Hills (MN); Hybrid; USD 60,000 - 114,000; Full time

Job summary

Boston Scientific seeks a Product Complaint Analyst II to analyze customer complaints in the Urology portfolio and determine regulatory reportability. You will perform investigations with clinical data, coordinate with internal teams and field reps, and prepare necessary regulatory submissions.

The role requires adherence to CFR and related regulations and offers a hybrid work model in which you visit the local office at least three days a week.

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 regulatory reportability and potential impacts to patient safety and business operations.
• Apply clinical knowledge to evaluate complaints and investigate data from clinical staff, field reps, internal staff, labs, and other sources.
• Establish regulatory reportability decisions using event investigation and regulatory 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 with timely submission to authorities.
• Accurately apply codes to events and review coding with engineering and laboratory staff.
• Compose written communications detailing observations, investigations, and corrective actions for physicians and end users.

Skills

Communication skills

Education

Bachelor’s degree or equivalent education

Biology/Health Sciences/Biotechnology/Engineering focus preferred

Job description

Boston Scientific seeks a Product Complaint Analyst II to analyze customer complaints in the Urology portfolio and determine regulatory reportability. You will perform investigations with clinical data, coordinate with internal teams and field reps, and prepare necessary regulatory submissions.

The role requires adherence to CFR and related regulations and offers a hybrid work model in which you visit the local office at least three days a week.