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Regulatory affairs associate Jobs in Sunnyvale, CA
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Regulatory Affairs Specialist
Kelly Science, Engineering, Technology & TelecomSunnyvale, CA, United States- Promoted
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Regulatory Affairs Specialist
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Kelly Science, Engineering, Technology & TelecomSunnyvale, CA, United States- Full-time
Regulatory Affairs Specialist I
Overview :
The Regulatory Affairs Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for client's in vitro diagnostic products. This role offers a unique opportunity to collaborate with cross-functional teams, including Technical Publications, Product Transfer, Quality, R&D, and Clinical Affairs, as part of client's global change control process. The position ensures regulatory compliance of product labeling and offers exposure to diverse array of in vitro diagnostic products, innovative technologies, and tools that implement continuous improvements and introduce new products to market.
Location : Sunnyvale, CA (Onsite)
Shift : M-F, standard working hours
Contract Duration : 3 months
Pay : $47-$50 / hr
Responsibilities
- Familiarization : Understand client's global change control process.
- Review and Implementation : Review change plans and implemented changes to product labeling / instructions for use.
- Cross-functional Collaboration : Partner with stakeholders to ensure accuracy in labeling changes.
- Regulatory Compliance : Work with the Technical Publications team to publish regulatory-compliant labeling for products.
Requirements :
Preferred Requirements :