Onsite Product Surveillance Analyst Regulatory & Quality

LiveHire Limited; Little Canada (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Job summary

Abbott is seeking an Analyst, Product Surveillance to analyze and submit complaints and investigate returned products from the field, some biohazardous due to surgical use. The role is 12-month contract to hire and 100% onsite at One St Jude Medical Drive, St. Paul, MN.

The position requires a 4-year science degree and experience in complaint handling and cross-functional communication. You will interface with physicians, hospital staff, sales reps, and international offices to determine

Qualifications

• 4-year degree science background; bio, chem, life sciences, etc.
• Complaint handling, investigation of product performance experience nice to have
• Highly organized – able to prioritize well
• Cross functional communication

Responsibilities

• Initiates and manages the product experience file. Maintains accurate entry of product experiences in the database.
• Triages new product experience report files from time to time.
• Communicates verbally and in writing with physicians, hospital personnel, sales representatives, and international offices.
• Maintains positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
• Independently assesses the product experience to determine if a medical device report needs to be filed with FDA or relevant authorities.
• Independently assesses the complaint to determine if an escalation is required.
• Ensures procedures and work instructions are maintained; supports inspections by regulatory agencies.
• Provides support to Legal Department regarding product complaints.
• Collaborates with cross-functional groups (QEs, R&D, medical affairs, education).
• May track returned products in the database; supports QMS, EMS and regulatory requirements.

Skills

Complaint handling

Cross functional communication

Highly organized

Education

4-year science degree

Job description

Abbott is seeking an Analyst, Product Surveillance to analyze and submit complaints and investigate returned products from the field, some biohazardous due to surgical use. The role is 12-month contract to hire and 100% onsite at One St Jude Medical Drive, St. Paul, MN.

The position requires a 4-year science degree and experience in complaint handling and cross-functional communication. You will interface with physicians, hospital staff, sales reps, and international offices to determine