Senior R&D Technical Writer - Transfusion and Transplant

Senior R&D Technical Writer – Transfusion and Transplant

Werfen North America is looking for a Senior R&D Technical Writer to prepare technical documentation supporting IVD design history files and regulatory submissions. The role requires a strong understanding of Quality Management Systems and global IVD regulations such as IVDR and 21

CFR
820. The position does not sponsor work authorization.

• Prepare all required R&D documentation for IVDR products to comply with EU MDR 2017/746 and/or FDA regulations.
• Review current or new product documentation and develop strategies with cross‑functional teams to fulfill regulatory requirements.
• 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 and support product performance compliance.
• Understand basic system functionality and operation of instrumentation and reagents to populate plans and reports.
• Identify and elevate potential document generation improvements to the appropriate organizations.
• Support audit activities (onsite or remote) by a competent authority.
• Ensure consistency, completeness, accuracy, and conformance to style guidelines.
• Execute gap analyses of commercialized IVD products, review reports, and provide guidance to project teams for updating technical documentation.
• Support responses to FDA and EU Notified Body during preparation and review of submissions.
• Mentor junior staff and provide on‑the‑job training and instructions.

• Demonstrate strong verbal and written communication skills.
• Write technical documentation clearly and legibly.
• Collaborate effectively with co‑workers and managers.
• Act as an effective team member and communicate knowledge of products, services, procedures and systems.
• Utilize Microsoft Office (Word, Excel), Track Wise, Master Control, SharePoint at an intermediate level.
• Prioritize multiple workloads and interact effectively with other departments.
• Maintain records and files of work and revisions following cGDP procedures and processes.

• BS/BA in a related discipline, or advanced degree; or equivalent combination of education and experience.
• 3+ years of experience in a regulated industry (medical device or pharma preferred).
• Experience working on multidisciplinary teams in a fast‑paced, dynamic environment.
• 3+ years of technical writing experience.

Seniority level:
Mid‑Senior level

Employment type:

Full‑time
Job function:
Marketing, Public Relations, and Writing/Editing
Industry: Medical Equipment Manufacturing

Location:

Atlanta, GA
Compensation: $81,120.00 – $