Project Manager/ Regulatory Affairs Project Manager - Intellectt INC

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 Europe Exp working in an ISO Certified environment.
• ISO 13485 Experience working in regulatory environment 5 years Exp.