What are the responsibilities and job description for the Medical Device Reporting Specialist || Contract-W2 || Atlanta, GA position at Tanisha Systems, Inc?
Position: Medical Device Reporting Specialist
2858 Woodcock Blvd (Davidson Building) Atlanta, GA 30341
Contract-W2
Must have Medical Device Reporting to the FDA or other countries (OUS).
They must know the different Medical Device Classification.
- 2 years of experience in medical device product quality complaints management / post market surveillance
- Knowledge of complaints management in medical device industry
- Good understanding on ISO 13485 or any other ISO/GxP Standard/Guidelines
- Able to write effective Medical and Technical narratives regarding the complaints
- Associate will be trained on client tools, platform, products, SOPs and templates
- Perform complaint decision trees and Vigilance Reporting as required
- Perform Reportability check of a complaint
- Perform clinical assessment of complaint
- Draft, review and submit vigilance reports
- Support regulatory and HA inquiries
- Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, and ISO13485.
- Able to write effective Medical and Technical narratives regarding the complaints.
- Must have good computer skills.
- Able to think critically and ask pertinent questions to gather necessary information.
- Good problem solving and analytical skills.
- Attention to detail.
Works autonomously within established procedures and practices to meet complaint timeline requirements
