Regulatory Compliance Specialist

2 weeks ago


Atlanta, Georgia, United States CorDx Full time
Job Title: Regulatory CoordinatorJob Summary

CorDx, a leading biotechnology company, is seeking a highly skilled Regulatory Coordinator to support the planning and execution of regulatory compliance activities. The ideal candidate will possess excellent organizational and communication skills, with a strong attention to detail and ability to interpret and communicate industry and regulatory guidance.

Key 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


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