Medical Record SpecialistTalentrupt RPO • Lafayette, CO, US
Medical Record Specialist
Talentrupt RPO • Lafayette, CO, US
22 hours ago
Job type
- Full-time
Job description1+ years of experience in complaint handling, customer service, or technical support 6+ months of experience in safety or clinical data evaluation 6+ months of experience in a medical device company or healthcare / pharmaceutical industry Ability to work independently or in a team setting Degree in Health Care, Sciences, or Biomedical Engineering Strong attention to detail Excellent oral and written communication skills, with strong organizational and analytical abilities Knowledge of basic anatomy, physiology, and medical terminology Strong problem-solving and critical thinking skills Bachelor’s degree 4-year degree Not specified (Nice to Have : 1+ years preferred)
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
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Medical Specialist • Lafayette, CO, US