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Remote Regulatory Writing Jobs in Georgia (NOW HIRING)

LivaNova

Regulatory & Clinical Specialist

Atlanta, GA · Remote

$85K - $95K/yr

... writing and medical device regulatory affairs or a Ph.D. with at least 3 years of experience Location & Travel Requirements * This is a remote role (candidates must be based in the United States)

FedEx Logistics

Sr Regulatory Advisor

East Point, GA · Remote

$4.9K - $9.4K/wk

Excellent communication skills, verbal and written. Organizational and problem solving skills ... This role is REMOTE **Candidates MUST reside within a 50 mile radius of one of the following ...

brs

Senior Technical Writer

San Antonio, TX · Remote

Persuasive Proposal Writing Techniques: Structuring detailed examples within response narratives ... remote, fast-moving proposal environment. Experience Qualifications * Experience supporting ...

CSAA

Write and review repair estimates, evaluate contractor estimates, and determine appropriate claim ... regulatory requirements. Required Experience, Education and Skills: * High school diploma or ...

New

SalvoHealth

Medical Assistant, Remote

Atlanta, GA · Remote

$18 - $22/hr

Ensure compliance with HIPAA regulations and maintain patient confidentiality * Provide general ... Excellent communication and interpersonal skills, both written and verbal * Strong organizational ...

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Remote Regulatory Writing information

What are the key skills and qualifications needed to thrive as a remote regulatory writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.
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What job categories do people searching Remote Regulatory Writing jobs in Georgia look for? The top searched job categories for Remote Regulatory Writing jobs in Georgia are:
What cities in Georgia are hiring for Remote Regulatory Writing jobs? Cities in Georgia with the most Remote Regulatory Writing job openings:
Remote Regulatory Writing jobs near you

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA • Remote

$99 - $100/hr

Full-time

Re-posted 10 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