Regulatory Affairs Specialist

Regulatory Affairs Specialist 3
Tarrytown, NY
7+ months contract to start with

The RA Technical Specialist Level 3 is a member of the TTN international RA team and is responsible for supporting international product registrations for ADVIA products. 
 
 Brief description of the primary accountabilities: 
 o Creates and implements strategies to support Siemens RU worldwide including Asia-Pacific, Middle East Asia, South and Latin America and Europe in registering ADVIA products 
 o Liaises with RA core team and design change team members to support product registrations worldwide. 
 o Various interdepartmental communications with marketing, manufacturing, R&D, OEMs, labeling, and others to support an efficient and effective international product registration process. 
 The position reports to the Sr. Manager, Regulatory Affairs. 
 
 Responsibilities: 
 o Interacts with other international RA colleagues to establish best practices. 
 o Effective interdepartmental communications. 
 o Organizes and supports international regulatory submission dossiers for ADVIA product line. 
 o Provides answers to technical questions from international regulatory authorities. 
 o Review and provide technical documents (test reports). 
 o Leads projects related to new product registrations, license renewals, and re-registration requests using RAPID database.
 
 Required Knowledge/Skills, Education, and Experience 
 o Advanced degree 
 o 4+ years regulatory affairs experience. 
 o Knowledge and experience with global registrations of IVDs. 
 o None or very minimal (?5%) 
 o Good technical writing skills 
 o Ability to read and interpret technical reports 
 o Knowledge of regulatory requirements worldwide 
 o Creative and adept at problem solving 
 o Effective communication skills 
 o Great focus with attention to detail 
 o Able to multi-task and work effectively in a dynamic environment 
 o Skilled in Outlook, Adobe Acrobat and Microsoft Office applications 
 o Able to work independently 
 
 Preferred Knowledge/Skills, Education, and Experience 
 o College degree in a scientific discipline. 
 o Experience communicating with non-native English speakers 
 o Experience in laboratory environment (e.g., Med Tech background) 
 o Bi-lingual, preferably mandarin 
 o Intercultural sensitivity 

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