Pay Range: $22/hr-$25/hr

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)

About the Role

• We are seeking a detail-oriented and critical thinker to join our team as a Complaint Handling Specialist.
• This role involves reviewing product events from various sources to determine complaint status and creating comprehensive complaint records in our system. 
• You will ensure all relevant information is gathered, conduct necessary follow-ups, determine regulatory reporting status, complete reports, and adhere to timeliness requirements.
• Participation in continuous improvement activities is also a key aspect of this role.

Responsibilities

• Review product events to determine complaint status and create detailed records.
• Ensure all relevant complaint information is provided and conduct follow-ups as needed.
• Determine regulatory reporting status and complete necessary reports. 
• Ensure compliance with timeliness requirements.
• Participate in continuous improvement activities. 
• Monitor the company's drug or medical devices surveillance program.
• Ensure accurate maintenance and reporting of Medical Device Reports (MDRs) and Adverse Drug Experience (ADE) data.
• Review and analyze clinical databases for ADE data extraction and integration.
• Act as a liaison internally and with external collaborators to meet regulatory reporting requirements.
• Deliver and oversee projects from design to implementation.

Education Qualification

• Bachelor's degree required.
• Preferred fields: Biomedical Engineering or Healthcare (e.g., Nursing).

Required Skills

• Strong critical thinking skills.
• Excellent attention to detail.
• Proficient writing ability.
• Ability to work with close supervision and deliver work of limited scope.
• Effective communication skills for internal collaboration.
• Ability to identify and address problems, making minor changes to systems and processes.
• Broad theoretical job knowledge typically obtained through advanced education.
• Work Location: Must be local to the Minneapolis/St. Paul area.
• On-site presence required at the Mounds View, MN.