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Truist Inc
Atlanta, GA, United States
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Job Source: Truist IncAzurity Pharmaceuticals - US
Atlanta, GA, United States
Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization.Ability to provide Advertising/Promotional regulatory insight in line with applicable regulatory guidelines. Serve as a liaison and subject matter expert (SMA) on the interpretation
Job Source: Azurity Pharmaceuticals - USAzurity Pharmaceuticals - US
Atlanta, GA, United States
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad com
Job Source: Azurity Pharmaceuticals - USDaiichi Sankyo
Atlanta, GA, United States
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise a
Job Source: Daiichi SankyoAveanna
Atlanta, GA, United States
Director, Regulatory Licensing ApplyRefer a FriendBack Job Details Requisition #: 194333 Location: Atlanta, GA 30339 Category: Management Salary: Starting at $100,000 per year Position Details Are you passionate about making a difference in people's lives through superior home healthcare? Look no further! Aveanna Healthcare is seeking dedicated ind
Job Source: AveannaCherokee Nation Businesses
Atlanta, GA, United States
Regulatory Health Scientist ***This position requires an active Secret clearance or the ability to obtain a Secret clearance to be considered. *** As required by our governmental client, this position requires being a US Citizen. Cherokee Nation Integrated Health (CNIH) is looking for a Regulatory Health Scientist to join our vibrant team
Job Source: Cherokee Nation BusinessesUnity Works Talent
Atlanta, GA, United States
About the job Director, Regulatory Licensing Location:Atlanta, GA 30339 Category: Management Salary: Starting at $100,000 per year Position Details: Current Opportunity: The Director, Regulatory Licensing is responsible for the coordination and completion of all government and regulatory filings for all business units/divisions in the organiz
Job Source: Unity Works TalentAveanna
Atlanta, GA, United States
Director, Regulatory Licensing ApplyRefer a FriendBack Job Details Requisition #: 194333 Location: Atlanta, GA 30339 Category: Management Salary: Starting at $100,000 per year Position Details Are you passionate about making a difference in people's lives through superior home healthcare? Look no further! Aveanna Healthcare is seeking dedicated ind
Job Source: AveannaAtlanta
Job Description Job Description 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
Email Alert for Regulatory Coordinator jobs in Atlanta
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