Lead Regulatory Affairs Analyst

2 weeks ago


Sunnyvale, California, United States Kelly Science, Engineering, Technology & Telecom Full time

Position Title: Senior Regulatory Affairs Consultant

Overview:

The Senior Regulatory Affairs Consultant plays a crucial role in assessing and ensuring the precision of labeling for in vitro diagnostic products. This position provides an exceptional opportunity to engage with various departments, including Technical Publications, Product Transfer, Quality Assurance, Research & Development, and Clinical Affairs, as part of the global change management process. The consultant is responsible for maintaining regulatory compliance of product labeling while gaining exposure to a wide range of diagnostic products and innovative technologies.

Key Responsibilities:

  • Process Familiarization: Acquire a comprehensive understanding of the global change management procedures.
  • Review and Execution: Analyze change proposals and implement modifications to product labeling and instructions for use.
  • Collaborative Engagement: Work closely with stakeholders to guarantee the accuracy of labeling modifications.
  • Regulatory Adherence: Collaborate with the Technical Publications team to produce labeling that meets regulatory standards.

Qualifications:

  • Bachelor's degree with a minimum of 5 years of relevant experience, or a Master's degree with at least 3 years of relevant experience, or a Doctoral degree with 0-2 years of relevant experience.
  • Thorough knowledge of regulatory affairs principles and familiarity with regulations and guidelines pertaining to diagnostic product development and labeling claims.
  • Understanding of Quality Management System regulations and standards governing change management and Corrective and Preventative Action (CAPA).
  • Proficiency in Microsoft Office Suite and Adobe Acrobat.

Preferred Qualifications:

  • Experience in labeling control and change management processes.
  • Familiarity with the CAPA process.
  • Experience with Agile documentation systems.


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