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Northside Hospital
Atlanta, GA | Full Time
$68k-90k (estimate)
3 Days Ago
CorDx
Atlanta, GA | Full Time
$64k-83k (estimate)
6 Days Ago
WIVERSE
Atlanta, GA | Temporary | Part Time
$58k-76k (estimate)
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WIVERSE
Atlanta, GA | Temporary | Part Time
$68k-85k (estimate)
2 Months Ago
Regulatory Coordinator
CorDx Atlanta, GA
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$64k-83k (estimate)
Full Time 6 Days Ago
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CorDx is Hiring a Regulatory Coordinator Near Atlanta, GA

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

Job Summary

JOB TYPE

Full Time

SALARY

$64k-83k (estimate)

POST DATE

04/29/2024

EXPIRATION DATE

05/18/2024

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CorDx
Full Time
$188k-246k (estimate)
Just Posted
CorDx
Full Time
$79k-103k (estimate)
5 Days Ago
CorDx
Full Time
$79k-103k (estimate)
5 Days Ago

The following is the career advancement route for Regulatory Coordinator positions, which can be used as a reference in future career path planning. As a Regulatory Coordinator, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Coordinator. You can explore the career advancement for a Regulatory Coordinator below and select your interested title to get hiring information.

CorDx
Full Time
$61k-79k (estimate)
5 Months Ago
WIVERSE
Temporary | Part Time
$68k-85k (estimate)
2 Months Ago
WIVERSE
Temporary | Part Time
$58k-76k (estimate)
2 Months Ago