Project Manager I

Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Santa Clara, CA for a Regulatory Affairs Project Manager role to assist their team. This is an on-site role.

Industry: Medical device
Title: Project Manager I
Pay Rate: $49/hr on W2
Location: Santa Clara, CA
Duration: 12 months Contrcat with possible extension or conversion

Regulatory Affairs Project Manager Job Roles & Responsibilities: -
Support IVDR compliance activities including creation of technical files, post market surveillance activities -
New product development documentation -
On market support: regulatory impact assessments, etc..

Regulatory operations:
BUDI number updates, label reviews, FDA laser report, state manufacturing license etc..

Product Develop
Regulatory Support
Impact Regulatory Support
Supporting Application for state license in US
5 years' experience
Organized Skillset
Be aware of regulations, Medical Device
IBDR for US and Europe
Exp working in an ISO Certified environment. ISO 13485
Experience working in regulatory environment
5 years Exp. Invitro Diagnostic Medical Devices is prefered