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Clinical Research Medical Writer

Bracane Company • Plano, Texas, United States • Part-time

$80,000

per year

Clinical Research Medical Devices Medical Writer Regulatory Affairs FDA submissions

Job Description

ROLE OVERVIEW:

We’re seeking an experienced Clinical Research Medical Writer to support a high-visibility medical device project. You will develop clear, compliant, and scientifically rigorous documentation across the product lifecycle, including submissions to the FDA (510(k) and De Novo).

KEY RESPONSIBILITIES:

Draft and edit clinical study protocols, other study specific documents, clinical evaluation reports, and study reports
Prepare regulatory submission documents, including 510(k) summaries, De Novo petitions, and labeling justifications
Create safety narratives, informed consent forms, and patient-facing materials
Collaborate with cross-functional teams (clinical operations, regulatory affairs, quality assurance) to gather data and ensure alignment
Maintain document version control, formatting, and adherence to company and FDA standards

QUALIFICATIONS:

Bachelor’s or advanced degree in Life Sciences, Nursing, Pharmacy, or related field
5+ years of medical writing experience in the medical device industry
Proven track record preparing FDA 510(k) and De Novo submissions
Familiarity with eCTD format, GCP, and ISO 14155 requirements
Excellent scientific writing, editing, and project-management skills
Strong attention to detail and ability to meet tight deadlines

LOCATION: Plano TX, Frisco TX, or Allen TX, or the surrounding area

POSITION: Part-time, Hybrid