Regulatory Coordinator

3 months ago


Atlanta, United States CorDx Full time
Job DescriptionJob 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


  • 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

    3 months 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...


  • Atlanta, Georgia, United States CorDx Full time

    Job OverviewPosition Summary: CorDx is seeking a committed Regulatory Affairs Specialist to oversee our compliance with FDA standards within the food and pharmaceutical sectors. The successful candidate will monitor regulatory developments, create compliance training programs, and work closely with multiple departments.Core Responsibilities:Thorough...


  • Atlanta, Georgia, United States Channel Personnel Services Full time

    Job OverviewA prominent global organization is seeking a Regulatory Compliance Manager to join their team. This position is critical for ensuring adherence to chemical control and product-related regulations while advocating for legislative matters across the Americas. The successful candidate will coordinate activities with research, technology,...

  • Global Regulatory Lead

    2 months ago


    Atlanta, United States UCB Full time

     Make your mark for patientsWe are looking for a Global Regulatory Lead to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta or Raleigh (US) offices. About the roleThe Global Regulatory Affairs Leader provides regulatory leadership to assigned Mission and/or asset. ...


  • Atlanta, Georgia, United States CliftonLarsonAllen Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented individual to join our Regulatory Compliance team at CliftonLarsonAllen. As a State and Local Tax, Telecom Associate, you will play a critical role in ensuring the accuracy and timeliness of regulatory documents and compliance functions.Key ResponsibilitiesCoordinate and compile accurate and...


  • Atlanta, United States Daiichi Sankyo, Inc. Full time

    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 and a...

  • The FDA Compliance

    4 weeks ago


    Atlanta, United States CorDx Full time

    Job DescriptionJob DescriptionDescriptionPosition Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. The FDA Compliance & Regulatory Specialist will also track and update FDA regulatory changes and collaborate with relevant...

  • The FDA Compliance

    3 months ago


    Atlanta, United States CorDx Full time

    Job DescriptionJob DescriptionDescriptionPosition Overview: The FDA Compliance & Regulatory Specialist is responsible for ensuring the company's compliance with FDA regulations and guidelines in the food and drug-related business. The FDA Compliance & Regulatory Specialist will also track and update FDA regulatory changes and collaborate with relevant...


  • Atlanta, Georgia, United States GeorgiaGov Full time

    Position Overview: The Regulatory Compliance Analyst plays a crucial role in overseeing the implementation of new or revised reporting standards and systems across the organization, collaborating with departmental personnel to gather and synthesize data while facilitating annual programmatic and financial evaluations. Key Responsibilities: Execute...


  • Atlanta, Georgia, United States PSSI Full time

    About Us:Packers Sanitation Services, Inc. (PSSI) is a leading food-industry-related contract sanitation and food safety company with over $1 Billion in sales and a strong history of organic and acquisition growth.Our Vision:We strive to be the leading food safety solutions company that owns the standard of health and safety for our PSSI family and brand...


  • Atlanta, Georgia, United States CorDx Full time

    Position Overview: The Regulatory Compliance Specialist at CorDx is tasked with ensuring adherence to FDA regulations and standards within the food and pharmaceutical sectors. This role involves monitoring and updating regulatory changes from the FDA and working closely with various departments to create compliance training and policies.Key...


  • Atlanta, Georgia, United States Veritiv Full time

    Job SummaryWe are seeking a highly skilled Sustainability Manager to join our team at Veritiv. As a key member of our sustainability team, you will play a critical role in ensuring our products and services meet the highest standards of environmental responsibility.Key ResponsibilitiesRegulatory Compliance: Provide guidance on Extended Producer...


  • Atlanta, United States Knowhirematch Full time

    Job DescriptionJob DescriptionPosition overviewMajor global and established company has an opportunity at their site in the Atlanta. GA metropolitan area due to an upcoming retirement for a Regulatory Compliance Manager that will be responsible for ensuring compliance with chemical control and other product-related regulations and for providing legislative...


  • Atlanta, Georgia, United States Takeda Pharmaceuticals Full time

    About the Position:As a Lead Manager in Regulatory Affairs Operations, you will play a pivotal role within the Vaccine Business Unit (VBU) to advance the mission of Regulatory Operations by facilitating health authority submissions, registrations, and archival processes, alongside managing Veeva RIM workflows and ensuring the accuracy of metadata in MEDIVA....


  • Atlanta, United States UCB Full time

     Make your mark for patientsWe are looking for a Patient & Regulatory Community Lead, Epilepsy Brands who has strong communication and relationship building with a patient-centric mindset to join us in our strategic planning and operations’ team, based in our Headquarters in Brussels, Belgium (preferred) or in Atlanta, Raleigh, Boston, US About...


  • Atlanta, Georgia, United States Arkadios Wealth Full time

    About UsArkadios Wealth is a leading SEC Registered Investment Advisor firm based in Atlanta, Georgia. As a fast-growing advisory firm, we support over 200 advisors nationwide through a comprehensive platform of innovative technology, multi-custodial clearing, and private wealth solutions. Established in 2017, we have been recognized by multiple publications...


  • Atlanta, Georgia, United States Bison Wealth, LLC Full time

    Join Our Team as a Compliance OfficerBison Wealth, LLC is on the lookout for a dedicated Compliance Officer to enhance our compliance framework. The successful candidate will possess a comprehensive grasp of regulatory standards and demonstrate the ability to communicate these effectively, along with a background in compliance within the investment advisory...


  • Atlanta, United States Southern Company Full time

    Job Description: The Project Manager will lead the preparation of reports and filings made to the Public Service Commission (PSC) including: New generation project Semi-Annual Reports, monthly reports, data requests and preparation for future filings. Additionally, the project manager will work together with Georgia Power and Southern Company Accounting,...


  • Atlanta, Georgia, United States American International Group Full time

    Position Overview This position is integral to the Regulatory Reporting team within the Commercial Auto sector. The role requires independent management of intricate projects while collaborating closely with brokers and underwriters. Key Responsibilities Engage and coordinate with internal departments as well as State Regulatory bodies.Ensure meticulous...