Medical Device Complaint Specialist

Job Description

Job title :
Medical Device Complaint Specialist

Client :
Medical Device Manufacturing Company

Duration : 24 Months

Location :
Mounds View, MN 55112

Shift : 1st Shift - 4 Days Onsite, 1 Day Remote

Description:

• Support Medical Device Report (MDR) activities.
• Review and process complaint records.
• Manage adverse event reporting.
• Monitor medical device surveillance.
• Maintain MDR and ADE records.
• Review clinical safety data.
• Prepare safety summaries and reports.
• Ensure regulatory compliance.
• Support complaint investigations.
• Collaborate with cross-functional teams.
• Maintain quality documentation.
• Support regulatory reporting projects.

Required Qualifications:

• Bachelor's degree required.
• 1-3 years of relevant experience.
• Medical Device Reporting (MDR) experience.
• Complaint handling experience.
• Knowledge of regulatory compliance.
• Strong analytical and critical thinking skills.
• Excellent organizational and time management skills.
• Strong written communication.
• Attention to detail.
• Ability to manage multiple priorities.

Preferred Qualifications:

• Clinical background (RN or Healthcare Professional).
• Biomedical Engineering background.
• Experience in a regulated environment.
• Knowledge of quality systems.
• Medical device industry experience.
• Experience with adverse event reporting.
• Cross-functional collaboration experience.