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Senior IVD Regulatory Technical Writer

Job in Norcross, Gwinnett County, Georgia, 30003, USA
Listing for: Werfen
Full Time position Listed on 2026-11-02
Job specializations:
  • Research/Development
    Regulatory Compliance Specialist, Research Scientist
Salary/Wage Range or Industry Benchmark: 90000 - 130000 USD Yearly USD 90000.00 130000.00 YEAR

Job Description & How to Apply Below

Werfen seeks a Sr. R&D Technical Writer to prepare technical documentation for IVDR and FDA submissions. You will work with Regulatory Affairs, Quality Control, Clinical Operations and Project Management to ensure compliant, precise documentation of products.

You will draft plans, protocols and reports, mentor junior staff, and contribute to continuous improvement of documentation practices. On-site work in Norcross, GA is required, with potential to influence global regulatory submissions.

Step into the Senior IVD Regulatory Technical Writer role at Werfen in Norcross, GA, United States and grow with us.

The Senior IVD Regulatory Technical Writer position in the Bio & Pharmacology & Health, Engineering field is open for applications.

We have an opening for a Senior IVD Regulatory Technical Writer in Norcross, GA, United States within Bio & Pharmacology & Health, Engineering.

Position Requirements

10+ Years work experience
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