Regulatory Affairs Quality Analyst (RAQA)
Florida, Fort Lauderdale
Our client, a Global Medical Device Manufacture has an immediate opening for a Regulatory Affairs Quality Analyst (RAQA) for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Effectively supports complaint handling process and processes complaints / MDR & Vigilance in a uniform and timely manner.
Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting and any other worldwide regulatory requirements.
Facilitates the timely initiation of complaints and closure of complaint investigations
Develop, prepare, and analyze trend reports for Complaints/ MDR monthly or quarterly as required.
Review of service tickets for input to the complaint process.
Partner with factory service and operations quality regarding the RMA process.
Assist in maintaining logs for other quality activities; non-conforming material, service, etc.
Works under general supervision with some latitude for independent judgment.
Must be proficient in Microsoft Word 2010, and other applications (Excel, PowerPoint, Adobe Acrobat, and Visio).
Experience with 21CFR820, Quality Systems Regulation and ISO 13495 desired.
Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several logs.
Must demonstrate the ability to multi-task and prioritize in a fast-paced environment, and possess flexibility when juggling numerous projects simultaneously.
Must grasp instructions and information rapidly and apply them with little supervision
Ability to work quickly and efficiently with only initial direction
Excellent organizational skills
Bachelor s degree required