Senior R&D Technical Writer - Transfusion

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

Senior R&D Technical Writer - Transfusion

Country

United States

Shift

1st

About the Position

Introduction

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’ll passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care

Overview

We are seeking a Sr. R & D Technical Writer who will be responsible for preparing technical documentation to support IVD design history files and regulatory submissions. Strong understanding of Quality Management Systems and Global IVD Regulations (including but not limited to IVDR and 21CFR820).driven and results-oriented Validation Engineer I to be responsible for assuring the successful execution of Werfen’s Validation Program.

This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Responsibilities

Additional responsibilities for Sr. R & D Technical Writer:

• Responsible for preparing all required R&D documentation for IVDR products to be in compliance with EU MDR 2017/746 regulation and/or FDA.
• Review current or new product documentation to develop strategies to align with cross-functional teams to fulfill the regulatory requirement.
• Collaborate with the Regulatory Affairs, Quality Control, Clinical Operations and Project Management organizations to determine requirements and draft/edit documentation for IVD products.
• Draft and develop plans, protocols and reports that explain and support the performance of a product to be in compliance.
• Understand basic system functionality and operation of instrumentation and reagents to populate plans and reports for the document of the product performance.
• Identify and elevate potential document generation improvements to the respective organizations.
• Support in proceeding the Audit (onsite or remote) activities by a competent Authority, as required by the team.
• Ensure, consistency, completeness, accuracy, and conformance to style guidelines.
• Responsible for executing a gap analysis of commercialized IVD products, reviewing reports, and providing guidance to Project Team for updating technical documentation.
• Support responses to FDA and EU Notified Body during the preparation and review of submissions.
• Strong attention to detail with organizational and technical writing skills.
• Mentor and assist in giving on-the-job training and instructions to junior staff

Additional Responsibilities:

• Demonstrates strong verbal and written communication skills.
• Displays ability to communicate clearly, write technical documentation clearly, legibly fill out documentation to communicate data and details as needed.
• Interacts cooperatively with co-workers and receives direction well from managers.
• Displays ability to be an effective team member.
• Demonstrates knowledge of products, services, procedures, policies, systems and company organization as it relates to job requirements.
• Displays PC skills with Microsoft Office (Word and Excel) and other software applications (TrackWise, MasterControl, SharePoint) functions at an intermediate level.
• Ability to prioritize multiple workloads.
• Interacts effectively with other departments.
• Maintain records and files of work and revisions according to procedures and processes by following cGDP.

Qualifications

Other qualifications for this role include:

• BS/BA in a related discipline, or advanced degree, where required, or equivalent combination of education and experience.
• 3+ years of experience within a Regulated Industry (medical device / pharma preferred.)
• Experience working on multidisciplinary teams in a fast-paced, dynamic environment.
• 3+ years of technical writing experience.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.