Regulatory & Compliance Specialist
CorDxSan Diego, California, United States
Posted August 22, 2024
90000 - 95000 USD year
Full Time
About the Company
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. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Job Description
CorDx is seeking a Regulatory & Compliance Specialist to ensure compliance with regulatory requirements for their in vitro diagnostic (IVD) products. The role involves working closely with cross-functional teams, supporting product development and post-market activities, and managing documentation related to diagnostic development. The specialist will oversee risk assessments, design reviews, and document preparation.
Requirements
- Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, and ISO 13485.
- Participate in risk management activities and maintain risk management files.
- Review and approve design control documentation.
- Support preparation of internal quality and regulatory documents.
- Review and approve design history file.
- Support preparation of regulatory submissions.
- Strong understanding of IVD product development and manufacturing processes.
- Excellent communication and analytical skills.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
