What are the responsibilities and job description for the Project Manager/ Regulatory Affairs Project Manager position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Affairs Project Manager
Location: Santa Clara, CA - 95054-1208
Duratio: 12 Months
Job Roles & Responsibilities: -
Location: Santa Clara, CA - 95054-1208
Duratio: 12 Months
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.
