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Regulatory Affairs Specialist
2 months ago
About CorDx
CorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 professionals worldwide, we serve millions of users across more than 100 countries. Our focus is on delivering rapid testing and point-of-care medical device solutions for the detection of infectious diseases, including COVID-19, pregnancy, substance abuse, biomarkers, and more. At CorDx, we are at the forefront of technology, artificial intelligence, and data science, aiming to provide diagnostic solutions to some of the most pressing challenges in healthcare.
Position Overview
Job Type: Full-time
Job Title: Regulatory Affairs Specialist
Location: Onsite - San Diego
Salary Range: $70,000 - $100,000
Key Responsibilities
- Assist in the development, submission, and upkeep of regulatory filings and registrations, including 510(k) and PMA submissions.
- Interpret and relay industry and regulatory guidance to internal teams.
- Collaborate with cross-functional teams to ensure adherence to regulatory standards.
- Oversee documentation related to regulatory submissions and approvals.
- Compile post-market surveillance reports, adverse event reports, and other regulatory documentation.
- Monitor and maintain regulatory compliance metrics.
- Engage in regulatory agency inspections.
Qualifications
- Fluency in English and Chinese.
- Bachelor's degree in biology, chemistry, or a related discipline.
- A minimum of 2 years of experience in regulatory affairs within the biotechnology sector.
- Familiarity with FDA regulations, including 21 CFR, 510(k), and PMA requirements.
- Strong organizational and project management capabilities.
- Exceptional written and verbal communication skills.
- Ability to work effectively with cross-functional teams.
- Detail-oriented with robust analytical skills.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
CorDx is an equal-opportunity employer that values diversity, recognizing that varied perspectives and backgrounds contribute to stronger teams. We are committed to fostering an inclusive environment and do not discriminate based on 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.
