Siemens HealthineersBusiness Unit:
Laboratory DiagnosticsRequisition Number:
United States-New York-TarrytownAssignment Category:
Full-time regularExperience Level:
Mid levelEducation Required Level:
Bachelor's DegreeTravel Required:
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