The FDA Compliance & Regulatory Specialist

Who is CorDx？  

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  

Job Type: Full time  
Job Title: The FDA Compliance & Regulatory Specialist
Location: Onsite - San Diego

Salary Range: $66,560 - $100,000

Position Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and...

Description

Position Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. The FDA Compliance & Regulatory Specialist will also track and update FDA regulatory changes and collaborate with relevant departments to develop compliance training and policies.

Responsibilities and Duties:

• Familiarize and understand FDA regulations, guidelines, and requirements, ensuring alignment of the company's business processes.
• Participate in preparing and submitting FDA approvals and registrations, providing compliance support and document management.
• Oversee and manage the company's compliance program, including developing compliance strategies, processes, and operating procedures.
• Track and interpret changes in FDA regulations and guidelines, as well as relevant industry dynamics and trends.
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