Quality/Regulagtory Systems Associate Engineer (Project Management)

Role:
We are currently seeking a self-motivated, charismatic individual to join our regulatory and quality engineering team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, this is your opportunity!
Essential Responsibilities:
Identifies regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards
Assists in preparation of premarket FDA, and international regulatory submissions, with technical review of data and reports
Assists in communication with regulatory agencies via pre-submissions and responses to premarket submission requests
Development and/or revision of Quality System procedures and processes
Internal and supplier audit development, implementation, and execution
Design Control documentation assistance
Validation and Testing Protocol support
Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements