Regulatory Affairs Ops Specialist Ii

Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Round Lake, IL OR Deerfield, IL. Generally onsite T, W, Th. for a Regulatory Affairs Ops Specialist II role to assist their team. This is an on-site role.
Industry: Medical device
Title: Regulatory Affairs Ops Specialist II
Location: HYBRID to Round Lake, IL OR Deerfield, IL. Generally onsite T, W, Th.
Duration: 5 Months contract with possible extension to 12 months
Job Description:
Just device experience would not be applicable because of how products are registered vs. solutions and how those products are registered
Role will support the US and could support the EU
Knowledge of CMC submission experience is needed
Assess change controls against the US (FDA) and EU (manufacturing, regulations, etc.) and make changes to report to FDA and EU
Ability to determine regulatory requirements and deliverables in a project team setting
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.