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 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:
Bachelor's degree with 2+ years of related work experience
Understanding of QMS regulations and standards (21 CFR Part 820 and EN ISO 13485) governing change management and CAPAs.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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