Regulatory Affairs Specialist 3
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.
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