Regulatory Affairs Project Manager (34110)

Job description

Job DetailsJob Location: Jacksonville, FL 32246Position Type: Full TimeEducation Level: 4 Year DegreeTravel Percentage: NoneJob Shift: DayJob Summary Responsible for leading project submission for regulatory approvals, acts to identify and resolve regulatory problems with respect to KLS-Martin L.P. and KLS Martin Manufacturing LLC. Exercises discretion and independent judgement related, but not limited to, domestic and international regulatory submissions and interfacing with regulatory authorities on the submissions. Essential Functions, Duties, and Responsibilities: Researches regulatory issues and provides supervision, guidance, and advice to cross functional team members Reviews labeling/advertising for compliance and regulatory requirements for compliance with submissions Oversight of design and development to include design history file as Regulatory Project Manager for KLS-Martin L.P. and KLS Martin Manufacturing product development process Review and identify domestic and/or international regulatory pathways for initial product designs and recommend changes or refinements based on initial regulatory outcomes Researches requirements (domestic and international) and provides...