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Regulatory Fda Technical Writer Jobs (NOW HIRING)

DivIHN Integration Inc

Technical Writer

San Diego, CA · On-site

Technical Writer Location: San Diego, CA Duration: 6 Months with possibilities of extension and ... A prior knowledge in clean room environments and FDA controlled industries would help to onboard ...

Manifest Solutions

Technical Writer

Columbus, OH · On-site

Translate moderate to complex technical and regulatory requirements into clear, concise language ... writing standards, and formatting conventions. * Coordinate with cross functional teams during ...

TRC Talent Solutions

Technical Writer

Greensboro, NC · On-site

$30/hr

The Technical Writer is responsible for developing, revising, and maintaining company manuals, forms, and technical documentation in compliance with FAA regulations and company standards. Key ...

Caresoft

Technical Writer

Rochester, NY · On-site

Title: Technical Writer Duration: 12 Months Location: Rochester NY Work model: Hybrid 2 days in ... Ensures publications adhere to established standards of style and format and meet regulatory ...

United Merchant Services

Technical Writer

Hackensack, NJ · On-site

$48K - $58K/hr

... regulatory requirements. * Work closely with the Compliance Director to review and revise ... Bachelor's degree in Technical Writing, English, Communications, or a related field. * Proven ...

Aegis Worldwide

Technical Writer

Hammond, IN · On-site

$32 - $36/hr

Exposure to safety, compliance, audit, or regulatory documentation. Ideal Candidate The ideal candidate is an organized and detail-oriented technical writer or document control professional who is ...

Codetech Inc

Technical Writer

Lansing, MI · On-site

Technical Writer 3, DTMB Agency Services Supporting MDARD DTMB Agency Services is seeking a ... regulations. Specific Position Experience Required: * Minimum 1 year mentoring and working with ...

The Fountain Group

Technical Writer

The role involves technical writing/editing within a software development environment and ensuring compliance with regulatory requirements. Responsibilities : • Responsible for designing ...

Integrated Resources INC

Technical Writer

La Verne, CA · On-site

Demonstrates knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and ... Demonstrates strong verbal, written, and interpersonal communication skills. Additional Information ...

MLS Technologies

Technical Writer

Huntsville, AL · On-site

Seeking a highly skilled Technical Writer to join our team and contribute to product documentation ... Knowledge of contracting documentation requirements, regulatory compliance, and security best ...

MLS Technologies

Technical Writer

Huntsville, AL

Seeking a highly skilled Technical Writer to join our team and contribute to product documentation ... Knowledge of contracting documentation requirements, regulatory compliance, and security best ...

Wisconsin

Technical Writer

La Crosse, WI · On-site

$47K/yr

The Technical Writer collaborates with subject matter experts (SMEs), leadership, and ... regulatory compliance. This is a one-year, project-based temporary position. This position is ...

New

Recruiting Engine (MLS)

Technical Writer

Huntsville, AL

$50 - $65/hr

Seeking a highly skilled Technical Writer to join our team and contribute to product documentation ... Knowledge of contracting documentation requirements, regulatory compliance, and security best ...

Manifest Solutions

Technical Writer

Columbus, OH

Translate moderate to complex technical and regulatory requirements into clear, concise language ... writing standards, and formatting conventions. * Coordinate with cross functional teams during ...

Saronic Technologies

Technical Writer

Austin, TX · On-site

Job Overview We are seeking a Technical Writer responsible for creating clear, concise, and ... Familiarity with DoD standards and regulations related to technical documentation is a plus

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Regulatory Fda Technical Writer information

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How much do regulatory fda technical writer jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for regulatory fda technical writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.

What is a Regulatory FDA Technical Writer?

A Regulatory FDA Technical Writer is a professional who specializes in creating and editing documents required by the U.S. Food and Drug Administration (FDA) for the approval and regulation of medical products such as drugs, medical devices, and biologics. Their responsibilities include writing, reviewing, and organizing submissions like INDs, NDAs, and 510(k)s, ensuring all documents comply with FDA guidelines and standards. They work closely with scientists, regulatory affairs teams, and subject matter experts to accurately present technical data and research findings. Their work is crucial for the successful approval and continued compliance of products within the healthcare industry.

What are the key skills and qualifications needed to thrive as a Regulatory FDA Technical Writer?

To thrive as a Regulatory FDA Technical Writer, you need a strong background in life sciences or technical fields and expertise in regulatory documentation and compliance standards. Familiarity with document management systems, regulatory submission portals (such as eCTD), and relevant FDA guidelines is essential. Exceptional written communication, attention to detail, and the ability to interpret complex scientific data are key soft skills that set candidates apart. These skills ensure the accurate, compliant, and timely submission of regulatory documents, which is crucial for successful product approvals and organizational compliance.

What are some common challenges faced by Regulatory FDA Technical Writers when preparing submission documents?

Regulatory FDA Technical Writers often face the challenge of interpreting and translating complex scientific data into clear, compliant documents that meet stringent FDA guidelines. Coordinating inputs from cross-functional teams—such as scientists, clinicians, and regulatory affairs—can also be demanding, particularly when timelines are tight. Additionally, keeping up with evolving FDA regulations and ensuring consistent document formatting and terminology are essential for successful submissions. Strong project management and communication skills are key to overcoming these challenges.

What is the difference between Regulatory Fda Technical Writer vs Regulatory Affairs Specialist?

AspectRegulatory Fda Technical WriterRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences or related field; certifications like RAC are commonRequires a degree in life sciences, pharmacy, or related; often holds RAC or similar certifications
Work EnvironmentFocuses on document creation, editing, and compliance documentation in regulated industriesInvolves regulatory strategy, submissions, and communication with authorities
Industry UsageUsed across pharmaceutical, biotech, and medical device companies for documentationEngaged in regulatory submissions, compliance, and product registration processes

While both roles require knowledge of FDA regulations and related certifications, Regulatory Fda Technical Writers primarily focus on preparing and editing technical documents, whereas Regulatory Affairs Specialists handle broader regulatory strategies and submissions. Both roles are essential in ensuring compliance within regulated industries.

What are popular job titles related to Regulatory Fda Technical Writer jobs?

For Regulatory Fda Technical Writer jobs, the most frequently searched job titles are:

Infographic showing various Regulatory Fda Technical Writer job openings in the United States as of September 2026, with employment types broken down into 60% Full Time, 20% Temporary, and 20% Contract. Highlights an 100% In-person job distribution, with an average salary of $81,001 per year, or $38.9 per hour.

Technical Writer

San Dimas, CA • On-site

Integrated Resources INC
Recruiting and Staffing Services • 51 - 200 employees
Learn more about Integrated Resources INCexternal

Contractor

Re-posted 12 days ago

Job description

Company Description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Job Description:

Demonstrates knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks.

Demonstrates analytical problem solving skills.

Demonstrates ability to explain complex concepts with clarity and simplicity.

Demonstrates ability to perform detail-oriented work with a high degree of accuracy.

Demonstrates strong verbal, written, and interpersonal communication skills.

Demonstrates proficiency in Microsoft Office applications and Adobe Acrobat Professional.

Previous experience in Pharmaceutical or Biotechnology industry, preferably in Quality Control.

Experience with leading info mapping or Kaizen process mapping. Comfortable with working individually and in a team setting with minimal supervision.

Experience and Details:

Mid-Level role with at least 3 years of experience in Pharma/Bio Tech.

Quality Control experience is good to have, but not required.

Candidate will be working on a project with the main duty to complete Info Mapping (aka Process Mapping).

They will refine and create new documents of existing processes; quality and tech points are captured in Info Mapping.

Will be working on multiple procedures and projects at the same time. Need to have an understanding of GMP Technical experience in MS Office and Adobe Acrobat is required Candidate traits: Strong team player, but will be working as an individual contributor (team consists of 3 people: Chemists and Microbiologists).

Think Analytically. Good writing skills

Additional Information

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.


Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (732)-844-8715

Gold Seal JCAHO Certified for Health Care Staffing

"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

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About Integrated Resources

Sourced by ZipRecruiter

Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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