Medical Writer Regulatory

U.S.-based medical device company at the final stages of our clinical program and preparing for a 510(k) submission. We are seeking an experienced Medical Writer with a strong background in regulatory writing for medical devices, specifically 510(k) and/or De Novo submissions. This is a contract role requiring full-time availability for the next couple of months.

The ideal candidate will be able to hit the ground running with minimal onboarding or training, and will have a proven track record of independently managing and delivering high-quality regulatory documentation.

Key Responsibilities

• Lead the preparation and writing of 510(k) submission documents, including clinical summaries, protocols, and supporting materials.
• Collaborate with cross-functional teams (Regulatory, Clinical, Quality, R&D) to gather and synthesize data.
• Ensure all documentation complies with FDA regulations and internal quality standards.
• Adapt quickly to a newly implemented documentation system and workflow.
• Deliver high-quality, submission-ready documents on tight timelines.

Qualifications

• Minimum 5+ years of experience in medical writing for medical device regulatory submissions.
• Demonstrated experience with 510(k) and/or De Novo submissions is required.
• Strong understanding of FDA regulatory requirements and guidance documents.
• Ability to work independently with minimal supervision.
• Excellent written and verbal communication skills.
• Experience with protocol development and clinical documentation.
• Familiarity with electronic document management systems (EDMS) is a plus.