Job Title:
Technical Writer IV Location:
Irving, TX – 100% Onsite Duration:
6 Months (Through 12/31/2025, with possible extension) Rate:
$45 – $50/hr (W2) Interview Process:
2 Rounds (Phone/Video) Position Summary:
We are seeking a highly detail-oriented
Technical Writer IV
with a strong background in the
medical device industry . The ideal candidate will support the creation, editing, and management of technical documentation to ensure
regulatory compliance
and
product testing standards
are met. This role will play a critical part in developing and revising
SOPs, forms, and procedures
for internal teams and regulatory bodies. Key Responsibilities:
Develop, write, and maintain accurate and compliant documentation including procedures, forms, testing instructions, and regulatory materials.
Translate complex technical concepts into clear and user-friendly content for engineers, QA professionals, and technicians.
Collaborate with cross-functional teams including R&D, Quality, and Process Owners to gather and validate documentation requirements.
Ensure all documentation complies with internal standards and
Good Documentation Practices (GDP) .
Manage document revisions, version control, and archival processes.
Support CAPA-related documentation and participate in usability studies and risk assessments.
Assist in the creation of internal SOPs and training materials.
Required Qualifications:
Minimum of
5+ years of technical writing experience
in
medical device ,
pharmaceutical , or
FDA-regulated
environments.
Proficiency with
document management systems
and
Microsoft Office .
Strong working knowledge of
medical terminology ,
regulatory writing standards , and
FDA documentation requirements .
Excellent written and verbal communication skills.
Ability to manage multiple projects with tight deadlines.
Must have experience working in an
onsite
role in a
regulated environment .
Preferred Experience:
Background in medical device, pharma, or other FDA-regulated industries.
Experience with
CAPA
documentation and
training SOPs .
Familiarity with ISO 13485 and other quality management systems.
Education:
Bachelor's degree in
English ,
Communications ,
Life Sciences ,
Engineering , or a related field.
Equivalent work experience may be considered in lieu of degree.
Technical Writer IV Location:
Irving, TX – 100% Onsite Duration:
6 Months (Through 12/31/2025, with possible extension) Rate:
$45 – $50/hr (W2) Interview Process:
2 Rounds (Phone/Video) Position Summary:
We are seeking a highly detail-oriented
Technical Writer IV
with a strong background in the
medical device industry . The ideal candidate will support the creation, editing, and management of technical documentation to ensure
regulatory compliance
and
product testing standards
are met. This role will play a critical part in developing and revising
SOPs, forms, and procedures
for internal teams and regulatory bodies. Key Responsibilities:
Develop, write, and maintain accurate and compliant documentation including procedures, forms, testing instructions, and regulatory materials.
Translate complex technical concepts into clear and user-friendly content for engineers, QA professionals, and technicians.
Collaborate with cross-functional teams including R&D, Quality, and Process Owners to gather and validate documentation requirements.
Ensure all documentation complies with internal standards and
Good Documentation Practices (GDP) .
Manage document revisions, version control, and archival processes.
Support CAPA-related documentation and participate in usability studies and risk assessments.
Assist in the creation of internal SOPs and training materials.
Required Qualifications:
Minimum of
5+ years of technical writing experience
in
medical device ,
pharmaceutical , or
FDA-regulated
environments.
Proficiency with
document management systems
and
Microsoft Office .
Strong working knowledge of
medical terminology ,
regulatory writing standards , and
FDA documentation requirements .
Excellent written and verbal communication skills.
Ability to manage multiple projects with tight deadlines.
Must have experience working in an
onsite
role in a
regulated environment .
Preferred Experience:
Background in medical device, pharma, or other FDA-regulated industries.
Experience with
CAPA
documentation and
training SOPs .
Familiarity with ISO 13485 and other quality management systems.
Education:
Bachelor's degree in
English ,
Communications ,
Life Sciences ,
Engineering , or a related field.
Equivalent work experience may be considered in lieu of degree.