QA Regulatory Affairs Specialist - Medical Devices

QA / Regulatory Affairs Specialist
This QA/RA Specialist is responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR). The QA/RA Specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).
Essential Functions:
- Manage and establish / maintain compliance with FDA QSRs (GMP) (including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of CAPA system)
- Responsible for the Documentation Control Process and Documentation Change Control Process
- Conduct internal audits and ensure closing of findings
- Establish / maintain compliance with the EU market directive and the Canadian MDR (including CE Mark applications or self-declarations via technical files)
- Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing
- Ensure compliance of labeling and advertising for all products in a regulated class
- Monitor and trend key quality objectives and present data to Senior management during management review meetings
Minimum Education (or substitute experience) required:
Bachelor of Science Degree
Minimum Experience Required:
At least 5 years experience in Quality Assurance and Regulatory Affairs for Medical Devices. Must have experience with scheduling and performing internal audits.
Skills Required:
- Excellent communication skills (verbal and written)
- Strong ability to handle multiple priorities simultaneously
- Meticulous attention to detail
- Ability to work in a team environment
- Good working knowledge of the Microsoft Office software

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