Regulatory Coordinator

4 weeks ago


San Diego, 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

  • 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


  • San Diego, 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...


  • San Diego, 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...


  • San Diego, 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...


  • San Diego, 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...


  • San Diego, 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...


  • San Diego, 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...


  • San Diego, 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...


  • San Diego, United States Blue Shield of California Full time

    Your Role The Appeals and Grievance Department Regulatory team is responsible for responding to inquiries received directly from our state regulatory agencies. The Regulatory Complaint Coordinator, Intermediate, will report to the Regulatory Complaint Supervisor. In this role you will be responsible for effectively managing your time daily to ensure you...


  • San Diego, United States Rady Children's Hospital-San Diego Full time

    JOB SUMMARY: In collaboration with the Director of Regulatory and Accreditation Programs, assists in all accreditation & regulatory activities, including survey preparation & readiness assessments for all facilities accredited by the Joint Commission. The position is very independent & deals with sensitive and confidential regulatory information daily. This...


  • San Diego, United States Cypress Human Capital Management, LLC Full time

    Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress Human Capital Management, LLC Full time

    Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress HCM Full time

    Regulatory Affairs Specialist The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinical study trials, including offsite location for trials when needed. Essential...


  • San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...


  • San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...


  • San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...


  • San Diego, United States Cypress HCM Full time

    The role involves providing global regulatory oversight and project leadership for assigned development products, reporting directly to the Vice President of Regulatory Affairs. The incumbent will contribute to and execute regulatory strategies to facilitate global product development, oversee regulatory communications with health authorities, and ensure...