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.