Regulatory Technical Specialist 3
12+months with possible extension
Terrytown-NY
Analyzes the requirements and prepares product related international regulatory submissions. * Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.* Identifies, analyzes and implements country specific requirements necessary for product related submissions.* Plans and prepares product related submissions with Siemens internal (e.g. Regional Units) or external organizations according to regulatory requirements. Submits required documentation/information to support international product registrations.* Ensures creation of adequate documentation for audits/inspections.* Performs training within the organization in country specific regulatory requirements "Transfers" Is expected to integrate processes and results from other workflows and disciplines to develop and accountably propose appropriate and effective solutions. 5-8 years Deep professional know-how and experience in one Sub Job Family. Masters domain and transfers and applies know-how to/in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches.
Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560