ZipRecruiter

Log In

2

Remote Regulatory Medical Writer Jobs (NOW HIRING)

Medasource

HEOR Medical Writer

Whippany, NJ · On-site +1

$30 - $40/hr

Remote Duration: 6 month contract with the potential for extension, based on performance Targeted ... regulatory and ethical guidelines (e.g., FDA/EMA, AMA style). • Maintain high standards for ...

BioMarin Pharmaceutical Inc.

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and document project ... Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD ...

ICON

Sr Medical Writer

Blue Bell, PA · On-site +1

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation ... Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation ...

New

Celerion

Medical Writer

Assure deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice ... medical or clinical results. * Professional writing and editing skills for accurate and concise ...

Veristat

The Principal Medical Writer independently plans and prepares a range of regulatory documents and ... Flexible, inclusive culture - 70% remote workforce, 66% women-led teams Learn more about our core ...

BioMarin Pharmaceutical Inc.

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and document project ... Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD ...

Revolution Medicines

Principal Medical Writer

$201K - $251K/yr

Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA ...

previous page

Showing results 41-60

All JobsRegulatory Medical Writer JobsRemote Regulatory Medical Writer Jobs

Remote Regulatory Medical Writer information

See salary details

$14

$38

$57

How much do remote regulatory medical writer jobs pay per hour?

As of Aug 3, 2026, the average hourly pay for remote regulatory medical writer in the United States is $38.64, according to ZipRecruiter salary data. Most workers in this role earn between $26.20 and $48.80 per hour, depending on experience, location, and employer.

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

AspectRemote Regulatory Medical WriterRemote Medical Writer
CredentialsMedical degree, regulatory writing experience, certifications (e.g., RAC)Medical, scientific, or related degree; writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory agenciesPharmaceutical, biotech, healthcare, or scientific organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsResearch publications, clinical trial documentation, scientific publications
Search/Comparison IntentRegulatory documentation, compliance, submission writingScientific writing, research, publication

The main difference is that Remote Regulatory Medical Writers focus on preparing regulatory documents for drug approvals and compliance, often requiring specific regulatory knowledge and certifications. Remote Medical Writers have a broader scope, including scientific publications and research documentation. Both roles require strong writing skills and relevant scientific backgrounds, but Regulatory Medical Writers specialize in regulatory submissions and compliance processes.

More about Remote Regulatory Medical Writer jobs
What cities are hiring for Remote Regulatory Medical Writer jobs? Cities with the most Remote Regulatory Medical Writer job openings:
What are the most commonly searched types of Regulatory Medical Writer jobs? The most popular types of Regulatory Medical Writer jobs are:
What states have the most Remote Regulatory Medical Writer jobs? States with the most job openings for Remote Regulatory Medical Writer jobs include:
What job categories do people searching Remote Regulatory Medical Writer jobs look for? The top searched job categories for Remote Regulatory Medical Writer jobs are:
Remote Regulatory Medical Writer jobs near you
Infographic showing various Remote Regulatory Medical Writer job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 78% Full Time, 14% Part Time, and 7% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA • Remote

$99 - $100/hr

Full-time

Re-posted 7 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