Technical Writer - Molecular Diagnostics (IFU Specialist)
Job Description
Job Description
Technical Writer (IFU & Labeling)
Location: Branchburg Township, NJ 08876
Schedule: Hybrid (3 days onsite, 2 days remote)
Shift: Monday-Friday, 1st Shift (8:00 AM-4:30 PM)
Employment Type: Contract
Zing is seeking a detail-oriented Technical Writer (IFU & Labeling) to support the development and maintenance of Instructions for Use (IFU) documentation and technical labeling for complex molecular diagnostic assays. This role will focus on translating scientific and technical information into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians.
The ideal candidate will have strong proofreading and editing skills, advanced Microsoft Word experience, and prior experience supporting medical device or in vitro diagnostics (IVD) documentation.
Responsibilities- Create, revise, and maintain Instructions for Use (IFUs) and Quick Reference Guides (QRGs) for molecular diagnostic products
- Develop and edit technical labeling documentation for regulated products
- Utilize advanced Microsoft Word functionality including nested numbering, cross-references, tables, templates, and multi-language layouts
- Perform detailed proofreading to ensure accuracy in scientific terminology, unit conversions, symbols, and formatting
- Ensure documentation complies with ISO 13485, FDA 21 CFR Part 820, IVDR, and internal quality standards
- Manage documentation throughout the full lifecycle within an Electronic Document Management System (EDMS)
- Collaborate with cross-functional teams including Regulatory, Quality, R&D, and Manufacturing to gather and validate content
- Coordinate and manage translation activities for IFUs and product labeling as needed
- Identify and resolve inconsistencies or discrepancies within complex datasets and technical documentation
- Associate Degree or equivalent combination of education, training, and recent, relevant industry experience is required
- Experience in technical writing within the Medical Device or In Vitro Diagnostics (IVD) industry
- Previous experience developing or supporting IFUs preferred
- Strong proofreading, editing, and document review skills
- Proficiency in Microsoft Office Suite, especially Microsoft Word
- Familiarity with IVDR and FDA documentation requirements
- Experience working within an Electronic Document Management System (EDMS)
- Strong attention to detail and organizational skills
- Ability to work independently and manage multiple documentation projects simultaneously
- Strong communication and collaboration skills
- Previous IFU writing experience
- Experience supporting multilingual documentation and translation workflows
- Experience working in a regulated laboratory, medical device, or diagnostics environment
- Hybrid work schedule with 3 days onsite and 2 days remote
- Interview process includes two virtual interview rounds
- Competitive compensation based on experience
Zing Recruiting is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace.
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Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.
Company Description
Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.
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