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 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
• Evaluate the company's existing compliance policies and procedures, provide improvement recommendations, and ensure effective implementation and compliance
• Assist in developing and implementing compliance training programs, ensuring employees' understanding and adherence to FDA requirements
• Assist in organizing and managing FDA audits and inspections and communicating and coordinating with regulatory agencies
• Collaborate with internal teams to ensure product development, manufacturing, labeling, and sales compliance
• Manage FDA-related records and documents to ensure compliance and timely archiving and documentation
• Share the latest compliance requirements and changes with the company's senior management and teams, providing compliance advice and guidance
  
  
  

Requirements

• Solid knowledge of FDA regulations and guidelines and a deep understanding of the food and drug industry
• Strong project management and organizational skills, capable of handling multiple compliance projects and tasks simultaneously
• Excellent communication and coordination abilities, able to collaborate with multiple stakeholders
• Analytical and problem-solving skills to interpret and address complex compliance issues
• Familiarity with the development and implementation of compliance training and awareness programs
• Excellent document management and record retention skills, with attention to detail and accuracy
• Experience in highly regulated industries such as food, pharmaceuticals, or medical devices
• A relevant bachelor's degree and prior experience in FDA compliance or regulatory affairs is preferred
  
  
  

Benefits

Medical Insurance Plan

Retirement Plan

Paid Time Off

Training & Development

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.