What are the responsibilities and job description for the Regulatory Affairs Project Manager position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Affairs Project Manager
Location: Santa Clara, CA - 95054
Duration: 12 Months
Shift Timings: 8 am to 5 pm
Job Duties
Location: Santa Clara, CA - 95054
Duration: 12 Months
Shift Timings: 8 am to 5 pm
Job Duties
- Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines.
- Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle.
- Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success.
- Deliver quality project solutions to business problems or issues within defined budgets and/or timelines.
- Provide expert project guidance/support proactively through project completion.
- Provide tracking, reporting, and presentation to management and users.
- 1-6 years experience
- 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..
