Regulatory Coordinator
2 weeks ago
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
- 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
- Health Care Plan (Medical)
- Retirement Plan
- Paid Time Off
- Training & Development
- Company Sponsored Meals
- Individual and Team Bonding Spending
-
Regulatory Coordinator
1 week ago
Atlanta, United States CorDx Full timeJob DescriptionJob DescriptionCorDx, 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...
-
Regulatory Coordinator
3 weeks ago
Atlanta, United States CorDx Full timeCorDx, 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...
-
Regulatory Coordinator
3 weeks ago
Atlanta, Georgia, United States CorDx Full timeCorDx, 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...
-
Clinical Research Regulatory Coordinator
2 weeks ago
Atlanta, United States Medix Full timeOverview: The Clinical Research Regulatory Coordinator plays a vital role in ensuring compliance with regulatory requirements and guidelines governing clinical research studies. This position involves liaising with regulatory authorities, preparing and submitting documentation, and maintaining accurate records to facilitate the smooth operation of clinical...
-
Clinical Research Regulatory Coordinator
4 days ago
Atlanta, United States Medix Full timeOverview: The Clinical Research Regulatory Coordinator plays a vital role in ensuring compliance with regulatory requirements and guidelines governing clinical research studies. This position involves liaising with regulatory authorities, preparing and submitting documentation, and maintaining accurate records to facilitate the smooth operation of clinical...
-
Clinical Research Regulatory Coordinator- 225565
2 weeks ago
Atlanta, United States Medix™ Full timeOverview: The Clinical Research Regulatory Coordinator plays a vital role in ensuring compliance with regulatory requirements and guidelines governing clinical research studies. This position involves liaising with regulatory authorities, preparing and submitting documentation, and maintaining accurate records to facilitate the smooth operation of clinical...
-
Clinical Research Regulatory Coordinator- 225565
2 weeks ago
Atlanta, United States Medix™ Full timeOverview: The Clinical Research Regulatory Coordinator plays a vital role in ensuring compliance with regulatory requirements and guidelines governing clinical research studies. This position involves liaising with regulatory authorities, preparing and submitting documentation, and maintaining accurate records to facilitate the smooth operation of clinical...
-
Clinical Research Regulatory Coordinator- 225565
2 weeks ago
Atlanta, United States Medix™ Full timeOverview: The Clinical Research Regulatory Coordinator plays a vital role in ensuring compliance with regulatory requirements and guidelines governing clinical research studies. This position involves liaising with regulatory authorities, preparing and submitting documentation, and maintaining accurate records to facilitate the smooth operation of clinical...
-
Director, Regulatory Licensing
4 weeks ago
Atlanta, United States Unity Works Staffing & Solutions Full timeJob DescriptionJob DescriptionLocation:Atlanta, GA 30339Category: ManagementSalary: Starting at $100,000 per yearPosition 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 organization. Works autonomously with...
-
Director, Regulatory Licensing
2 weeks ago
Atlanta, United States Unity Works Staffing & Solutions Full timeJob DescriptionJob DescriptionLocation:Atlanta, GA 30339Category: ManagementSalary: Starting at $100,000 per yearPosition 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 organization. Works autonomously with...
-
Director, Regulatory Licensing
4 weeks ago
Atlanta, Georgia, United States Unity Works Staffing & Solutions Full timeLocation:Atlanta, GA 30339 Category: Management Salary: Starting at $100,000 per year Position Details: Current Opportunity: ...
-
Regulatory Affairs Specialist Project Lead I
4 days ago
Atlanta, United States Integrated Resources Full timeJob Title: Regulatory Affairs Specialist Project Lead I Location: Washington D.C., DC (Fully Remote) Duration: 06 months + Part-Time Role- (Mon - Fri 9 AM - 1 PM EST) Job Description: Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones) No issue with dual part-time employment simultaneously,...
-
Administrative Assistant
2 days ago
Atlanta, Georgia, United States Nuclear Regulatory Commission Full timeThe successful candidate will serve as the principal administrative assistant to one or more branch chiefs of the Division of Reactor Projects, performing the full range of administrative duties.Such duties include but are not limited to:Prepares letters, memoranda and reports in final form from drafts, entering them into ADAMS.Reviews and proofreads...
-
Regional Manager, Regulatory Affairs
2 weeks ago
Atlanta, United States Symmetrio Full timeSymmetrio is currently recruiting a qualified individual to fill the role of Regional Manager Regulatory Affairs & Quality Americas for our client, a global medical device company. The successful candidate will be responsible for overseeing the functions and team, for the North and South Americas Region, in alignment with the department's defined directions...
-
Regional Manager, Regulatory Affairs
4 weeks ago
Atlanta, United States Symmetrio Full timeJob DescriptionJob DescriptionSymmetrio is currently recruiting a qualified individual to fill the role of Regional Manager Regulatory Affairs & Quality Americas for our client, a global medical device company. The successful candidate will be responsible for overseeing the functions and team, for the North and South Americas Region, in alignment with the...
-
Regional Manager, Regulatory Affairs
2 weeks ago
Atlanta, United States Symmetrio Full timeJob DescriptionJob DescriptionSymmetrio is currently recruiting a qualified individual to fill the role of Regional Manager Regulatory Affairs & Quality Americas for our client, a global medical device company. The successful candidate will be responsible for overseeing the functions and team, for the North and South Americas Region, in alignment with the...
-
Credentialing Coordinator
2 weeks ago
Atlanta, United States SCP ENT & Allergy Services, LLC Full timeThe Credentialing Coordinator is responsible for ensuring that healthcare professionals meet all necessary requirements and qualifications to obtain and maintain their credentials. This position plays a critical role in ensuring compliance with regulatory standards and facilitating the smooth operation of the credentialing process. The Credentialing...
-
Credentialing Coordinator
2 weeks ago
Atlanta, United States SENTA Partners Full timeDescription The Credentialing Coordinator is responsible for ensuring that healthcare professionals meet all necessary requirements and qualifications to obtain and maintain their credentials. This position plays a critical role in ensuring compliance with regulatory standards and facilitating the smooth operation of the credentialing process. The...
-
Credentialing Coordinator
4 days ago
Atlanta, United States SENTA Partners Full timeDescription The Credentialing Coordinator is responsible for ensuring that healthcare professionals meet all necessary requirements and qualifications to obtain and maintain their credentials. This position plays a critical role in ensuring compliance with regulatory standards and facilitating the smooth operation of the credentialing process. The...
-
Atlanta, Georgia, United States Emory University Full timeDiscover Your Career at Emory University: Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the diversity and excellence of our academic community. Description: The Director, Treasury Operations and...