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
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