Medical Record Specialist

Job Description

Job Description

Job Title : Medical Record Specialist

Location : Lafayette, CO 80026

Position Type : Hybrid (4 days onsite, 1 day remote)

Pay Rate :   $30 / hr

Duration : 12 months

Job Description / Responsibilities

• Identify and document appropriate complaint categories to ensure trend accuracy within the complaint database.
• Write investigation summaries based on technical product analysis information provided.
• Maintain record documentation in a constant state of audit readiness per internal policies.
• Review, evaluate, classify, and perform follow-up activities on all product complaints regarding the identity, quality, reliability, safety, and effectiveness of medical devices.
• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance as needed during complaint processing.
• Process complaints in the Global Complaint Handling System, supporting the Respiratory Interventions (RI) Operating Unit, in accordance with company policies and regulatory requirements.
• Perform complaint intake activities, make regulatory decisions, submit regulatory reports to competent authorities, and provide letters to customers.
• Monitor the company’s drug or medical device surveillance program, including intake, protocol development, evaluation, processing, and follow-up on adverse reports, and participate in resolution of legal liability and compliance with government regulations.
• Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
• Act as liaison with internal and external complaint handling partners to ensure timely and accurate processing of complaints.
• Collaborate internally and with external partners to develop programs and processes to meet regulatory reporting requirements.

Nice to Have

Must Have

Education Required

Years of Experience Required