The RA Specialist Level 2 is a member of the TTN international RA team and is responsible for supporting international product registrations for ADVIA Centaur, Atellica Solutions, and new generation products. Performance objectives are as follows:
o Prepares and sends regulatory submission dossiers for ADVIA Centaur and Atellica Solutions product lines.
o Provides supporting documents for Product Change Notifications to Siemens Regional Units (RU) worldwide using TRAID TeamSpace.
o Liaises with RA design change team members to obtain supporting documents (test reports, labeling, etc.).
o Submits applications to government agencies for Free Sale Certificates to support global registrations.
o Liaises with Legal Department on country-specific registration and tender 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 Potential to lead international product registration projects and tasks as needed.
Requirements include 4 year College degree, 3+ years regulatory experience, knowledge and experience with Medical devices or IVDs, experience with international regulatory agencies, good focus with attention to detail, ability to learn and interpret technical reports, creative and adept at problem solving, able to multi-task and work effectively in a dynamic environment
Skills in Outlook, Adobe Acrobat and Microsoft Office applications are also required.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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