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Three Point Solutions, Inc.
Medical Device Complaint Specialist
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Based on Colorado data
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What they do
A Medical Writer applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe the research results, product use, and other medical information. Medical writers may also offer writing support to the principal investigators for grant applications and specialized publications.
$77,799 / year median in Colorado
+4% projected growth
Job Description
Job Title:
Medical Device Complaint Specialist Client:
Medical Device Manufacturing Company Duration:
6 Months (Possibility of Extension)Location:
Lafayette, CO 80026Shift:
1st Shift (Onsite 4 days/week, Remote 1 day/week)Description:
- Evaluate, process, and investigate product complaints and adverse events in compliance with FDA and global regulatory requirements.
- Prepare and maintain accurate Medical Device Reports (MDRs) and complaint documentation.
- Manage complaint intake, case processing, reporting, and follow-up activities.
- Support regulatory reporting programs and improve complaint handling processes.
- Maintain complaint databases and ensure investigations are completed accurately and on time.
- Collaborate with cross-functional teams to resolve product quality and regulatory issues.
- Ensure compliance with GDP, GMP, quality systems, and company procedures.
- Support assigned projects and provide guidance to entry-level team members when needed.
Required Skills:
- Medical Device Complaint Handling
- Medical Device Reporting (MDR)
- Regulatory Compliance
- Technical Writing
- Microsoft Office (Outlook, Word, Excel)
- Database Management
- Attention to Detail
Communication & Documentation Preferred Skills:
- Medical Terminology
- Good Documentation Practices (GDP)
- Good Manufacturing Practices (GMP)
- Quality Systems
- Database / OneNote Experience
Science, Healthcare, or Engineering Background Education:
- Bachelor's degree in Science, Healthcare, Engineering, or a related field.
Experience:
- 0-2 years of experience in medical devices, healthcare, regulatory affairs, quality, or complaint handling.