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Regulatory Fda Technical Writer Jobs (NOW HIRING)

Konik

Technical Writer

Saint Paul, MN

$28 - $37/hr

Technical Writer Eagan, MN | On-Site | Contract to Hire | $28 - $37/hr Konik is partnering with a ... S. government regulations, candidates must be U.S. citizens to be considered for clearance.

Entegrity Consulting Group

Technical Writer

Dayton, OH · Remote

The Technical Writer will collaborate with various technical staff, ensuring all documentation is clear, concise, accurate, and compliant with established standards and regulatory requirements. This ...

Pegasus Knowledge Solutions

Technical Writer

Durham, NC · On-site

Our client is seeking two Technical Writers to support standards development, seed documentation ... regulations, and technical frameworks; also, strong documentation skills and attention to detail ...

Catalent, Inc.

Technical Writer

Greenville, NC · On-site

... strong regulatory track record, making it a critical part of Catalent's global network for ... Provide requested information during client and FDA audits * Participate in cross-functional ...

RWDC Industries

Be Seen First

Technical Writer

Athens, GA · On-site

Support compliance efforts with applicable regulatory requirements Continuous Improvement ... Associates degree in Technical Writing, Journalism, Education, Communications, Engineering ...

Urgent

Saronic Technologies

Technical Writer

Austin, TX · On-site

The Technical Writer will be responsible for creating clear, concise, and comprehensive ... any relevant DoD regulations and guidelines • Review and edit documentation for accuracy ...

MNCP Staffing

Technical Writer

Reno, NV

... regulatory teams, operations personnel, and executive stakeholders to translate complex technical ... The Technical Writer serves as a key resource in standardizing project controls documentation ...

ProSidian Consulting

Technical Writer

Charlotte, NC · Remote

This is accomplished through the development of workplace standards, regulations, and guidance that ... Technical Writer Candidates shall work to support requirements for PR0001 Communications And ...

Saronic Technologies

Technical Writer

Austin, TX · On-site

They are seeking a Technical Writer responsible for creating clear and comprehensive documentation ... any relevant DoD regulations and guidelines • Review and edit documentation for accuracy ...

RWDC Industries

Be Seen First

Technical Writer

Athens, GA · On-site

Support compliance efforts with applicable regulatory requirements Continuous Improvement ... Associates degree in Technical Writing, Journalism, Education, Communications, Engineering ...

Urgent

Three Point Solutions

Technical Writer

Northridge, CA · On-site

$20 - $22/hr

Technical Writer Client: Medical Device Manufacturing Company Duration: 6 Months (Possible ... Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams. * Organize technical ...

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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

Saint Paul, MN

Konik
51 - 200 employees
Learn more about Konikexternal

$28 - $37/hr

Full-time, Contractor

Medical, Dental

Re-posted 8 days ago

Job description

Technical Writer

Eagan, MN | On-Site | Contract to Hire | $28 - $37/hr
Konik is partnering with a growing defense engineering company in the south metro area to hire a Technical Writer. This Technical Writing role will focus on developing and maintaining Interactive Electronic Technical Manuals (IETM) for complex defense and engineering products. Our client fosters a collaborative, team-oriented environment. This is a contract-to-hire opportunity; our client has a strong track record of converting contract employees to full-time roles after an initial contracting period. If you're a detail-oriented Technical Writer passionate about creating high-quality, structured documentation for defense, aerospace, or complex engineering products, we encourage you to apply!
Technical Writer Responsibilities:

  • Create, organize, and edit technical content following style and terminology standards
  • Collaborate with subject matter experts to research and interpret product specifications
  • Develop and update user procedures, technical manuals, and illustrations
  • Ensure consistency and clarity across documentation and maintain version control
  • Use authoring tools including XML/S1000D, PTC Arbortext, Microsoft Office, Adobe Illustrator, and Acrobat
  • Maintain and update documentation libraries as products evolve

Technical Writer Qualifications:

  • Bachelor's degree in Technical Writing, English, Science, or related field
  • 2+ years of Technical Writing experience
  • Experience working on technical manuals (ideally interactive electronic technical manuals) in an engineering or manufacturing setting
  • Experience with XML based authoring tools such as Arbortext or similar; knowledge of S1000D or similar standards is preferred
  • Strong verbal and written communication skills
  • Ability to manage multiple priorities and meet deadlines
  • This position requires eligibility to obtain and maintain a U.S. Secret security clearance. Per U.S. government regulations, candidates must be U.S. citizens to be considered for clearance.

Benefits:

  • Health & dental insurance
  • Paid holidays
  • MN Earned Sick & Safe Time
  • Weekly paychecks
  • Eligible for Overtime


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Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.
Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception, and maintains a strong commitment to customer service.

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