Regulator Affairs Specialist

Senior Regulatory Affairs Specialist I

Overview :

The Regulatory Affairs Senior Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for Cepheid'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 Cepheid'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 (Hybrid)

Shift : M-F, standard working hours

Contract Duration : 6 months

Pay : $50 / hr

Responsibilities

• Familiarization : Understand Cepheid'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 Cepheid products.

Requirements :

• Bachelor's degree with 5+ years of related work experience OR Master's degree with 3+ years of related work experience OR Doctoral degree with 0-2 years of related work experience.
• In-depth understanding of regulatory affairs concepts and familiarity with regulations / guidelines for diagnostic product development and labeling claims.
• Understanding of QMS regulations and standards (21 CFR Part 820 and EN ISO 13485) governing change management and CAPA.
• Skilled with Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat.

Preferred Requirements :

• Experience in labeling control and change management.
• Familiarity with the Corrective and Preventative Action (CAPA) process.
• Experience with Agile documentation systems.

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