Regulatory MDR & Complaint Analyst II (Medical Devices)

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

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Product Complaint Analyst II to analyze customer complaints for regulatory reportability within the Urology portfolio and coordinate with internal teams, field staff, and end users. The role requires adherence to CFR regulations and involves preparing regulatory reports and communications.

The position follows a hybrid work model requiring attendance in the local office at least three days per week, with relocation not available.

Qualifications

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

Responsibilities

• Review complaint communications and assess complaints for regulatory reportability and impact on patient safety and business operations.
• Gather data from clinical staff, field representatives, internal employees, and labs to investigate complaints.
• Determine regulatory reportability decisions using event investigation models and regulatory standards.
• Contribute to development and modification of decision models for product advances and therapies.
• Write Medical Device Reports (MDRs) and other regulatory reports and ensure timely submission to authorities.
• Apply proper coding to events and review investigations with engineering and lab teams.
• Prepare clear written communications detailing observations and actions for physicians and end users.

Skills

Communication skills

Time management

Critical thinking

Education

Bachelor’s degree or equivalent education

Job description

Boston Scientific is seeking a Product Complaint Analyst II to analyze customer complaints for regulatory reportability within the Urology portfolio and coordinate with internal teams, field staff, and end users. The role requires adherence to CFR regulations and involves preparing regulatory reports and communications.

The position follows a hybrid work model requiring attendance in the local office at least three days per week, with relocation not available.