Regulatory Coordinator

2 weeks ago


Atlanta, United States CorDx Full time

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


  • Atlanta, United States CorDx Full time

    Job 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

    Found in: Appcast Linkedin GBL C2 - 5 days ago


    Atlanta, United States CorDx Full time

    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...

  • Regulatory Coordinator

    Found in: Resume Library US A2 - 2 weeks ago


    Atlanta, Georgia, United States CorDx Full time

    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...

  • Clinical Research Regulatory Coordinator- 225565

    Found in: Appcast US C2 - 4 days ago


    Atlanta, United States Medix™ Full time

    Overview: 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

    Found in: Appcast Linkedin GBL C2 - 4 days ago


    Atlanta, United States Medix™ Full time

    Overview: 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...


  • Atlanta, United States Medix™ Full time

    Overview: 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...


  • Atlanta, United States Unity Works Staffing & Solutions Full time

    Job 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...


  • Atlanta, United States Unity Works Staffing & Solutions Full time

    Job Description Job Description 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 organization. Works autonomously...


  • Atlanta, United States Unity Works Staffing & Solutions Full time

    Job 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

    Found in: Resume Library US A2 - 3 weeks ago


    Atlanta, Georgia, United States Unity Works Staffing & Solutions Full time

    Location:Atlanta, GA 30339 Category: Management Salary: Starting at $100,000 per year Position Details:                                                                                                                    Current Opportunity: ...

  • Regulatory Affairs Lead, USA

    Found in: Talent US C2 - 2 weeks ago


    Atlanta, United States JM Huber Corporation Full time

    Summary The Regulatory Affairs Lead supports the Regulatory Information Management System (RIMS) for the Huber Agriculture Solutions (HAS) business unit and external customer systems. This position provides expertise for regulatory affairs projects supporting business maintenance and / or growth and right to operate (RTO) Monitor & communicate...


  • Atlanta, United States Symmetrio Full time

    Symmetrio 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...


  • Atlanta, United States Symmetrio Full time

    Job 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

    Found in: Appcast Linkedin GBL C2 - 5 days ago


    Atlanta, United States Symmetrio Full time

    Symmetrio 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...


  • Atlanta, United States Symmetrio Full time

    Job 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...


  • Atlanta, United States Symmetrio Full time

    Symmetrio 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...

  • Airport Operations Representative I

    Found in: Jooble US O C2 - 4 days ago


    Atlanta, GA, United States City of Atlanta Full time

    General Description and Classification Standards Performs duties associated with functions assigned to the regulatory compliance operations groups. Provides additional operational support in the terminals and concourses as airport business dictates. Performs duties related to aviation security, physical security, access control, and customer service...

  • Air Import Coordinator

    Found in: Appcast Linkedin GBL C2 - 3 days ago


    Atlanta, United States ALS Recruiting Ltd Full time

    Job Title: Air Import CoordinatorCompany Overview: Join a dynamic and forward-thinking logistics company dedicated to providing seamless transportation solutions to our clients worldwide. We pride ourselves on our commitment to excellence, efficiency, and customer satisfaction. As an Air Import Coordinator, you'll play a pivotal role in our operations,...

  • Air Import Coordinator

    Found in: Appcast US C2 - 2 days ago


    Atlanta, United States ALS Recruiting Ltd Full time

    Job Title: Air Import CoordinatorCompany Overview: Join a dynamic and forward-thinking logistics company dedicated to providing seamless transportation solutions to our clients worldwide. We pride ourselves on our commitment to excellence, efficiency, and customer satisfaction. As an Air Import Coordinator, you'll play a pivotal role in our operations,...

  • Coordinator of Government and Community Affairs.

    Found in: Talent US 2 C2 - 2 weeks ago


    Atlanta, United States GeorgiaGov Full time

    Atlanta Technical College (ATC) is currently accepting applications for the Coordinator of Government and Community Affairs position in the Communications and Marketing division . This position reports to the Vice President of Communications, Marketing & PR and will be located at at ATC’s Main/South Campus, is just South of Downtown Atlanta. The Director...