Compliance Coordinator
1 week ago
Company Overview:
CorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 individuals worldwide, we cater to millions across over 100 nations, providing rapid testing and point-of-care medical device solutions for the detection of infectious diseases, including COVID-19, pregnancy, substance abuse, biomarkers, and more. Our commitment to technology, artificial intelligence, and data science positions us at the forefront of delivering diagnostic solutions to critical healthcare inquiries.
Position Details:
Job Type: Full-time
Job Title: Regulatory Coordinator
Location: Onsite
Salary Range: $70,000 - $100,000
Key Responsibilities:
- Assist in the preparation, submission, and ongoing management of regulatory filings and registrations, including 510(k) and PMA submissions.
- Interpret and convey industry and regulatory guidance to internal stakeholders.
- 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 necessary regulatory documentation.
- Monitor and maintain metrics related to regulatory compliance.
- 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.
Employee Benefits:
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
CorDx is an equal-opportunity employer that values diversity. We recognize that a variety of perspectives and backgrounds contribute to stronger teams. Our commitment to diversity and inclusion is serious and thoughtful, ensuring that we 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.
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