🛠 Tech Stack

💼 About This Role

You'll prepare and manage regulatory documents for the PMA submission of a Class III diagnostic device for colorectal cancer screening. You'll play a critical role in ensuring compliance with FDA requirements and translating complex scientific data into precise content. This role is pivotal in our mission to detect cancer earlier.

🎯 What You'll Do

• Develop and author technical documents for PMA submissions.
• Collaborate with cross-functional teams to ensure accuracy.
• Review and edit documents for compliance with FDA guidelines.
• Manage document lifecycle and version control.

📋 Requirements

• Bachelor's degree in scientific or related field.
• 3-5 years of experience as a Technical Writer in medical devices.
• Direct involvement in FDA regulatory submissions (PMA preferred).
• Proficiency in technical writing tools like Microsoft Word and Adobe Acrobat.

✨ Nice to Have

• Certification in medical writing (e.g., AMWA) or regulatory affairs (RAC).
• Experience with diagnostic assays or molecular diagnostics.
• Knowledge of international regulatory standards (EU MDR/IVDR).

🎁 Benefits & Perks

• 🎉 22 days PTO plus carryover 10 days.
• 🎂 Birthday off and company holidays.
• 🏥 Medical, dental, vision insurance plus life, STD, LTD, 401(k).
• 📅 Flexible work schedule.

📨 Hiring Process

Estimated timeline: 2-3 weeks · AI estimate

1. 1Recruiter Call· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Assessment· 60 min