Siemens Careers

Regulatory Technical Spec 2

Tarrytown, New York
Quality Management

English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 231382
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: No

Division Description:


Job Description:

o       The RA Specialist Level 2 is a member of the TTN international RA team and provides support for the registration of ADVIA products worldwide. 
o       Manage existing PCN process. 
o       Supports and completes product registrations through RAPID database.
o       Prepares and sends regulatory submission dossiers for ADVIA product line.
o       Sends Product Change Notifications to Siemens RU worldwide, collates responses and follows through on completing necessary tasks.
o       Provides supporting documents (test reports, labeling, etc.). 
o       Obtains Certificates (CFG, FSC) to support registration. 
o       Liaises with Legal Department on country-specific letters.
o       Submits documents for legalization and manages the process.
o       Reviews and prepares China-specific registration letters, manages the process of notarization and sending documents.
o       Able to work independently on international product registration projects and tasks as needed.
Required Knowledge/Skills, Education, and Experience
o       Bachelor’s degree.
o       3+ years regulatory affairs experience
o       Knowledge and experience with Medical devices or IVDs.
o       Experience with regulatory agencies. 
•        Required amount of travel with the position
o       None or very minimal (<5%).
o       Good focus with attention to detail
o       Willingness to learn to interpret technical reports
o       Knowledge of regulatory requirements worldwide
o       Creative and adept at problem solving
o       Able to multi-task and work effectively in a dynamic environment
o       Skilled in Outlook, Adobe Acrobat and Microsoft Office applications.
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       Demonstrated interest in having a career in regulatory affairs.
o       Good technical writing skills
o       Intercultural sensitivity
o       Bilingual

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