Job Description: This position is responsible for assisting Director of RA in regulatory activities including management of regulatory databases, providing document review, labeling review and coordination with multiple personnel and/or departments.
Essential Duties & Responsibilities:
Other duties may be assigned. Manage regulatory.
Research technical requirements for regulatory databases
Assist in technical interface between RA, marketing and Labeling personnel
Access technical files and update as directed
Assist in preparation of regulatory submissions (Tech Files, Design Files and 510(k)s)
The ability to research technical topics (product materials and attributes) / problem solving ability; ability to summarize, desired.
Must be detail-oriented and work in team environment.
Must be able to maintain confidentiality in dealing with regulatory documents
Strong interpersonal skills in the areas of written and verbal communication
Must be able to prioritize and handle multiple projects concurrently
Must be self-motivated and able to work independently
High level of proficiency in the use of a personal computer with proficiency in the use of the MS Office Suite
Must be able to meet goals on time
High School or equivalent required.
Associate degree in scientific discipline preferred.
Regulatory Affairs Certification (RAC) a plus
One (1) or more years’ experience in medical device / FDA regulated industry preferred, experience with US FDA submissions a plus Experience with Tech File maintenance a plus Language Skills:
Must have command of the English language and should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data.
Must demonstrate ability to review documentation in order to determine varying product attributes. Ability to solve practical problems and knowledge of when to seek guidance.
Primary Work Location: East Syracuse, NY