Regulatory Coordinator

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: Regulatory Coordinator
Location: Onsite - San Diego

Salary Range: $66,560 - $75,000

Requirements

• Assist in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.
• Maintain and organize regulatory documentation, including regulatory submissions, approvals, certificates, and correspondences with health authorities.
• Work closely with R&D, quality assurance, and manufacturing teams to obtain required documentation in compliance with regulatory guidelines and product development life cycle.
• Maintain current knowledge of relevant regulations, guidance documents, and standards.
• Provide administrative and project support to the Regulatory Affairs team, including scheduling meetings, preparing agendas, and drafting regulatory reports.
• Support internal audits and assist in maintaining compliant regulatory documentation according to Quality Management System and in accordance with ISO 13485 and other relevant standards.

Requirements:

• Bachelor's degree in biology, chemistry, regulatory affairs or a related field.
• 2+ years of experience in regulatory affairs, preferably in IVD or medical device industry.
• Familiarity with FDA regulations, including 21 CFR, 510(k), and ISO 13485 requirements.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams.
• Detail-oriented with strong analytical skills.

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.