Regulatory Coordinator

CorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal candidate will be detail-oriented and possess excellent organizational and communication skills.

Responsibilities

• Assist in the preparation, submission, and maintenance of regulatory filings and registrations, including 510(k) and PMA submissions.
• Interpret and communicate industry and regulatory guidance to internal teams.
• Coordinate with cross-functional teams to ensure compliance with regulatory requirements.
• Manage documentation related to regulatory submissions and approvals.
• Prepare post-market surveillance reports, adverse event reports, and other regulatory reports.
• Track and maintain regulatory compliance metrics.
• Participate in regulatory agency inspections.

Requirements

• Proficient in English and Chinese
• Bachelor's degree in biology, chemistry, or a related field.
• 2+ years of experience in regulatory affairs in the biotechnology industry.
• Knowledge of FDA regulations, including 21 CFR, 510(k), and PMA 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

• Health Care Plan (Medical)
• Retirement Plan
• Paid Time Off
• Training & Development
• Company Sponsored Meals
• Individual and Team Bonding Spending