Technical Writer - Molecular Diagnostics (IFU Specialist)

Technical Writer - Molecular Diagnostics (IFU Specialist)#26-13553 Branchburg, NJ All On-site Job Description

Description:

Job Title:

Technical Writer (IFU & Labeling)

Working Model:

Hybrid (3 days on site, 2 days remote)

Working Days:

M-F 1st shift

Working Hours:

0800-1630

Roche Bill Rate:

•

Interview Model:

Two rounds total - virtual

Key Skills Required:

MS Office, Proofing, previous IFU knowledge preferred.

Education Requirements:

Min. Associates Degree or equivalent Job description Lead the end-to-end development, writing, and rigorous editing of Instructions for Use (IFU) and technical labeling for complex molecular diagnostic assays. Translate complex scientific data into clear, compliant, and user-friendly documentation for laboratory professionals and clinicians.

Key responsibilities include:

Creating and revising IFUs and Quick Reference Guides (QRGs) for molecular diagnostic products. Utilizing advanced Microsoft Word skills for complex document structures (nested numbering, cross-references, tables, multi-language layouts). Performing meticulous proofreading to ensure accuracy in scientific terminology, unit conversions, and symbol usage; adhering to

ISO 13485, FDA 21 CFR

Part 820, and IVDR. Managing full document lifecycle within an Electronic Document Management System (EDMS). Partnering with cross-functional stakeholders to gather content and ensure alignment. Managing translations of IFUs and labeling as needed. Who You Are Proficient in MS Office Strong proofing and editing skills Comfortable working independently through the IFU lifecycle High attention to detail and strong organizational skills 2-4 years of industry experience in Medical Device or In Vitro Diagnostics (IVD) technical writing of IFUs Familiarity with regulatory requirements (IVDR, FDA) Experienced in collaborating with cross-functional teams to meet project deadlines Ability to spot minor discrepancies in large, complex datasets Preferred (Optional) Previous IFU knowledge Associates Degree or equivalent level of education in a scientific discipline, technical writing, or other related technical field

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."