Technical Writer

Real Staffing Group; North Haven (CT); Hybrid; USD 74,000 - 105,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Technical writing

InDesign

Framemaker

XML tools

PLM tools

Verbal communication

Written communication

Education

University degree in related field

Tools

InDesign

Framemaker

XML tools

PLM tools

Job description

Medical Device Company

Technical Writer

Location-

This role is primarily based onsite in North Haven, CT, with consideration for candidates located in Lafayette, CO, or Mounds View, MN.

Contract- 1 year W2

Hourly rate- 65/hour

Start date- 11/16

A leading organisation is seeking a Technical Writer to join its engineering team, supporting medical device labeling for Core Surgical/RST business units. This role is primarily based onsite in North Haven, CT, with consideration for candidates located in Lafayette, CO, or Mounds View, MN. The position requires onsite presence four days per week, with one day remote.

The Technical Writer will plan, research, develop, and update Instructions for Use and other labeling materials, ensuring alignment with cross-functional feedback and compliance with standards and robust quality processes. Responsibilities include managing labeling deliverables as part of project teams, supporting approvals in PLM tools, facilitating translation requests, and assisting with launch activities for both electronic and hardcopy distribution. The role involves simultaneous management of labeling updates and new product introduction projects, conducting interviews with users and technical staff to gather data, and recommending documentation formats responsive to technical and customer requirements.

Additional duties include overseeing the Engineering Change Order process for labeling, coordinating and tracking translations, completing labeling proofs, developing documentation for regulatory submissions, and assisting with CAPAs and audits. The Technical Writer will participate in project and team meetings, collaborate with teams to finalize documentation, and contribute to departmental initiatives.

Candidates should have a university degree and a minimum of five years' relevant experience, or an advanced degree with at least two years' experience. Strong collaboration, verbal and written communication skills, and technical writing competencies are essential. Experience with authoring tools such as InDesign, Framemaker, and XML tools, as well as familiarity with complex regulatory environments and quality processes, is required.

Must-Have Skills: technical writing, InDesign, Framemaker, XML tools, PLM tools

Nice-to-Have Skills: collaboration, verbal communication, written communication, regulatory environments, quality processes, project management, illustration development

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.