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Remote Regulatory Writing Jobs (NOW HIRING)

Danaher

Staff Global Regulatory GPO

Chaska, MN · On-site +1

... remote. In this role, you will have the opportunity to: * Develop, implement and execute global ... Develop clear written assessments and stakeholder-ready presentations to communicate regulatory ...

LivaNova

Regulatory & Clinical Specialist

Chicago, IL · 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)

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)

LivaNova

Regulatory & Clinical Specialist

Phoenix, AZ · 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)

LivaNova

Regulatory & Clinical Specialist

Charlotte, NC · 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)

LivaNova

Regulatory & Clinical Specialist

Houston, TX · 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)

LivaNova

Regulatory & Clinical Specialist

Boston, MA · 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)

LivaNova

Regulatory & Clinical Specialist

Dallas, TX · 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)

LivaNova

Regulatory & Clinical Specialist

Minneapolis, MN · 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)

LivaNova

Regulatory & Clinical Specialist

Denver, CO · 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)

LivaNova

Regulatory & Clinical Specialist

Austin, TX · 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)

SonicWall

Regulatory Manager

Excellent written and verbal communication skills in English. * Ability to work effectively across ... LI-KB7 #LI-Remote #wireless SonicWall is an equal opportunity employer. We are committed to ...

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How much do remote regulatory writing jobs pay per hour?

As of Jul 10, 2026, the average hourly pay for remote regulatory writing in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

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.
More about Remote Regulatory Writing jobs
What cities are hiring for Remote Regulatory Writing jobs? Cities with the most Remote Regulatory Writing job openings:
What are the most commonly searched types of Regulatory Writing jobs? The most popular types of Regulatory Writing jobs are:
What states have the most Remote Regulatory Writing jobs? States with the most job openings for Remote Regulatory Writing jobs include:
What job categories do people searching Remote Regulatory Writing jobs look for? The top searched job categories for Remote Regulatory Writing jobs are:
Remote Regulatory Writing jobs near you
Infographic showing various Remote Regulatory Writing job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Manager - Regulatory Affairs (Remote)

Manager - Regulatory Affairs (Remote)

Caris Life Sciences

Remote

$124K - $152K/yr

Full-time

Re-posted 4 days ago

Job description

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives.
We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: "What would I do if this patient were my mom?" That question drives everything we do.
But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose.
Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
Position Summary
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions. This position will have a variety of responsibilities to include preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new guidance from various regulatory agencies.
Job Responsibilities
  • Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
  • Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
  • Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, IDEs, supplements, and technical files for CE marketing.
  • Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.
  • Review and provide regulatory input on analytical and clinical study protocols.
  • Provide support, as needed, for FDA inspections, Pre-Approval Inspections or European Notified Body Inspections.
  • Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes.
  • Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.
  • Support compliance activities associated with the Quality Management System to fulfill with international and domestic policies and regulations.

Required Qualifications
  • Bachelor's degree in a science-related area of study.
  • Minimum of 6 years hands-on submission experience including the developing and execution of regulatory strategies for medical device and/or IVD regulated products.
  • Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products.
  • Strong understanding of product development process, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies.
  • Ability to work independently, taking ownership for the management of processes, projects, and timelines.
  • Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.

Preferred Qualifications
  • Master's degree in a science-related area of study.
  • Prior experience with in vitro diagnostics.
  • Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
  • Experience leading and/or supporting US FDA submissions.
  • Experience in writing/maintaining CE Technical Files.
  • Ability to mentor and lead others through challenging circumstances.

Physical Demands
  • Employee may be required to lift routine office supplies and use standard office equipment.
  • Ability to sit/stand for extended periods of time while using a computer.

Training
  • All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other
  • This position may require periodic travel and some evenings, weekends and/or holidays.

Annual Hiring Range
$124,000.00 - $152,000.00
Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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