Senior R&D Technical Writer - IVD Regulatory Lead

Werfenlife SA.; Norcross, Northern (GA, KY); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Werfen is seeking a Senior R&D Technical Writer to prepare documentation supporting IVDR, FDA submissions, and regulatory filings for transfusion products. The role requires meticulous attention to detail, strong organizational and technical writing skills, and the ability to work across functions.

You will collaborate with Regulatory Affairs, Quality Control, Clinical Operations, and Project Management to ensure compliant documentation.

Qualifications

• BS/BA in a related discipline or advanced degree, or equivalent combination of education and experience.
• 3+ years of experience within a regulated industry (medical device/pharma preferred).
• 3+ years of technical writing experience.

Responsibilities

• Prepare R&D documentation for IVDR products to be in compliance with EU MDR 2017/746 and/or FDA.
• Collaborate with Regulatory Affairs, Quality Control, Clinical Operations and Project Management to determine requirements and draft/edit documentation for IVD products.
• Draft and develop plans, protocols and reports that explain product performance and stay in compliance.
• Understand instrumentation/reagent operation to populate plans and reports for product performance.
• Support responses to FDA and EU Notified Body during submissions; mentor junior staff.

Skills

Attention to detail

Written communication

Team collaboration

Education

Bachelor's degree or higher

Tools

TrackWise

MasterControl

SharePoint

Job description

Werfen is seeking a Senior R&D Technical Writer to prepare documentation supporting IVDR, FDA submissions, and regulatory filings for transfusion products. The role requires meticulous attention to detail, strong organizational and technical writing skills, and the ability to work across functions.

You will collaborate with Regulatory Affairs, Quality Control, Clinical Operations, and Project Management to ensure compliant documentation.