Medical Device Labeling Technical Writer (Hybrid)

Real Staffing Group; North Haven (CT); Híbrido; USD 74.000 - 105.000; Jornada completa

Descripción de la vacante

Real Staffing Group is seeking a Technical Writer to join the engineering team for medical device labeling across Core Surgical/RST units. The role is based onsite in North Haven, CT, with one remote day per week and four onsite days.

The writer will develop and update Instructions for Use, manage labeling deliverables, and support regulatory submissions and translations. Strong collaboration, InDesign/FrameMaker/XML/PLM proficiency, and the ability to handle complex quality processes are

Formación

• Minimum five years of relevant experience, or an advanced degree with at least two years of experience.
• Experience with medical device labeling and regulatory environments is preferred.
• Strong collaboration and communication skills are essential.

Responsabilidades

• Plan, research, develop, and update Instructions for Use and labeling materials.
• Manage labeling deliverables within project teams and support approvals in PLM tools.
• Coordinate and facilitate translations and launch activities for electronic and hardcopy distributions.
• Oversee labeling updates and new product introduction projects; interview users and technical staff to gather data.
• Develop documentation formats responsive to technical and customer requirements and assist with CAPAs and audits.

Conocimientos

Technical writing

InDesign

Framemaker

XML tools

PLM tools

Verbal communication

Written communication

Educación

University degree in related field

Herramientas

InDesign

Framemaker

XML tools

PLM tools

Descripción del empleo

Real Staffing Group is seeking a Technical Writer to join the engineering team for medical device labeling across Core Surgical/RST units. The role is based onsite in North Haven, CT, with one remote day per week and four onsite days.

The writer will develop and update Instructions for Use, manage labeling deliverables, and support regulatory submissions and translations. Strong collaboration, InDesign/FrameMaker/XML/PLM proficiency, and the ability to handle complex quality processes are