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Remote Fda Scientist Jobs in Georgia (NOW HIRING)

LIMS SME/Business Analyst

Atlanta, GA ยท Remote

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

This is a remote position so the candidate can live anywhere in the USA. The position will require ... Provide strategic direction to the IT, Scientific, and Management teams. Define data migration ...

Field Clinical Specialist

Atlanta, GA ยท Remote

$75K - $81K/yr

Field Clinical Specialist Remote/Field role InspireMD is a dynamic growing company focused on ... Support FDA inspections and audits, ensuring that all regulatory and complaint handling ...

Compliance Officers

South Fulton, GA ยท Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Compliance Officers

Savannah, GA ยท Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Director of Biostatistics

Columbus, GA ยท Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Compliance Officers

Sandy Springs, GA ยท Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Biostatistician

South Fulton, GA ยท Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Director of Biostatistics

Athens, GA ยท Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Biostatistician

Savannah, GA ยท Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Director of Biostatistics

Augusta, GA ยท Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

Biostatistician

Augusta, GA ยท Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... Collaborate with project stakeholders to ensure deliverables align with regulatory and scientific ...

Regulatory Affairs Specialist

Athens, GA ยท Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.

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Showing results 1-20

Remote Fda Scientist information

What is a remote FDA scientist?

A Remote FDA Scientist is a professional who works for or with the U.S. Food and Drug Administration (FDA) from a remote location, rather than onsite at an FDA facility. These scientists are involved in a variety of regulatory, research, and review activities related to food, drugs, medical devices, or other products overseen by the FDA. Their responsibilities may include evaluating scientific data, reviewing submissions from manufacturers, and ensuring products meet safety and efficacy standards. Remote FDA Scientists typically collaborate with colleagues and stakeholders through virtual communication tools while maintaining strict compliance with federal guidelines.

What are the key skills and qualifications needed to thrive as a remote FDA scientist?

To thrive as a Remote FDA Scientist, you need a strong background in life sciences or a related field, advanced analytical skills, and experience with regulatory compliance, often supported by a relevant degree (such as a PhD or MS) and prior FDA or industry experience. Familiarity with data analysis tools, regulatory submission systems (like eCTD), and quality management software is typical. Excellent written communication, attention to detail, and the ability to work independently are vital soft skills in this role. These competencies ensure accurate scientific evaluation, effective regulatory submissions, and compliance with FDA standards while working remotely.

What are some common challenges faced by remote FDA scientists in maintaining effective communication with regulatory teams?

Remote FDA Scientists often navigate the challenge of ensuring clear and timely communication with cross-functional regulatory teams, especially when working across different time zones. This role requires proactive use of collaboration tools, regular virtual meetings, and detailed documentation to keep everyone aligned on project goals and compliance requirements. Building strong relationships with colleagues and setting clear expectations for updates and feedback can help mitigate miscommunication and support project success. Additionally, staying organized and being responsive to regulatory changes are key to thriving in a remote environment.

What is the difference between Remote Fda Scientist vs Remote Fda Reviewer?

AspectRemote Fda ScientistRemote Fda Reviewer
Required CredentialsAdvanced degree in life sciences, relevant certificationsSimilar credentials, often with additional regulatory training
Work EnvironmentResearch labs, regulatory agencies, or remote settingsPrimarily review submissions remotely, office or home-based
Industry UsageResearch, development, and regulatory complianceReviewing and approving drug, device, or food applications
Common Search IntentUnderstanding roles, qualifications, and remote opportunitiesDifferences in responsibilities, qualifications, and remote work

Remote Fda Scientists focus on research and development activities, while Remote Fda Reviewers primarily evaluate submissions for approval. Both roles require similar scientific credentials and often operate remotely within the regulatory industry. The main difference lies in their core responsibilities: scientists conduct research, whereas reviewers assess regulatory submissions.

What are the most commonly searched types of Fda Scientist jobs in Georgia?

The most popular types of Fda Scientist jobs in Georgia are:

What cities in Georgia are hiring for Remote Fda Scientist jobs?

Cities in Georgia with the most Remote Fda Scientist job openings:

Infographic showing various Remote Fda Scientist job openings in Georgia as of June 2026, with employment types broken down into 83% Full Time, and 17% Part Time. Highlights an 35% Physical, 3% Hybrid, and 62% Remote job distribution.

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA โ€ข Remote

$99 - $100/hr

Full-time

Re-posted 22 days ago


Job description

Remote Regulatory Affairs contractor requires:

  • Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
  • 5-10 years+ of global medical device regulatory experience
  • Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
  • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
  • Strong working knowledge of:
    • FDA regulations (21 Parts 807, 820)
    • FDA guidance documents and eStar requirements
    • Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
  • Demonstrated ability to work independently as a contractor in a fast-paced environment
  • Experience filing medical device submissions in China and other countries
  • Experience with audiology devices
  • Experience with artificial-intelligence enabled devices
  • Strong technical writing and documentation skills
  • Ability to translate complex technical information into regulatory submissions
  • Detail-oriented with strong organization skills
  • Effective communicator across technical and non-technical stakeholders
  • Ability to manage multiple deliverables and timelines

DUTIES:

  • FDA 510(k) submission
  • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
  • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
  • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
  • Lead submission lifecycle activities, including:
    • Acceptance Review support (RTA readiness)
    • Substantive Review coordination
    • Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
    • Updating submission content and modules as required
  • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
  • Provide regulatory leadership through FDA clearance.
  • EU MDR Technical Documentation Support
  • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
  • Perform critical review and gap analysis of EU MDR technical file
  • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
  • Lead or support submission to obtain CE Mark
  • Health Canada submission
  • Global Regulatory Strategy and Advisory