Regulatory Affairs Specialist 3

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APN Software Services, Inc
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.
Contract W2, 6+ Months
Depends On Experience
Telecommuting not available Travel not required

Job Description

Please contact Abdul on "510.623.5049" OR email me at "abdul@apninc.com"

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: 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 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 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

Please contact Abdul on "510.623.5049" OR email me at "abdul@apninc.com"

Posted By

Abdul Mohammed

39899 Balentine Dr #385 Newark, CA, 94560

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Company Information

At APN we strive to be the best in the industry. We enjoy a challenge, embrace competition and we are committed to providing the finest services to our clients. We are a close-knit team of high-tech professionals. We place strong emphasis on continuing education for our consultants, and we sponsor various training programs, which relate to consultant's growth, client projects and current technology requirements. In addition to competitive pay, APN Software Services Inc. provides free career advice, resume counseling, interview assistance and much more!
Dice Id : apn
Position Id : SIMNJP00045029