Senior Technical Writer Entegee - 3.7 Irvine, CA Job Details Contract $50 - $60 an hour 1 hour ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Medical writing Customer communication Illustration Labeling Adobe Illustrator Graphic design Graphic design software Regulatory affairs Technical writing Biomedical regulatory compliance Prepress software Adobe InDesign FDA regulations Product lifecycle management Full Job Description Sr. Technical Writer | Irvine, CA | Onsite | $50-60/hr

Duration:

24 months

Schedule:

Monday-Friday, 40 hours/week Work authorization: U.S. Citizen required

Interview:

Phone and video

Start:

Within two weeks We are seeking a Senior Technical Writer to lead the development and lifecycle management of customer-facing labeling content and artwork for medical devices. This hands-on role supports new product development and sustaining initiatives, creating clear, compliant Instructions for Use (IFUs), user guides, electronic labeling and packaging materials. The ideal candidate brings deep medical-device labeling expertise along with strong Adobe InDesign and Illustrator skills.

Responsibilities:

Create, revise and release IFUs, user guides, electronic labeling and preprinted packaging artwork Develop accurate, user-focused content from complex technical and regulatory information Create and maintain artwork files using Adobe InDesign and Adobe Illustrator Ensure labeling meets

FDA, EU MDR, IMDRF, UDI, IEC 60601, ISO

20417 and

ISO 15223

requirements Partner with R D, Regulatory Affairs, Quality, Marketing, Clinical and Medical Safety teams Support change orders, design-control deliverables, traceability, reviews and verification documentation Support product launches, sustaining work, version control and legacy-document updates Monitor regulatory changes and provide practical labeling guidance to project teams

Requirements:

Master's degree in Regulatory Affairs or an engineering discipline At least 6 years of medical-device technical writing, labeling development or technical communications experience Strong expertise with medical-device IFUs and labeling content requirements Advanced Adobe InDesign and Adobe Illustrator experience, including artwork-file creation Knowledge of global labeling standards and regulations U.S. Citizen status required Able to work onsite in

Irvine, CA Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPA 1647799

Sr Technical Writer Pay:

$50.00 - $60.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance People with a criminal record are encouraged to apply Application Question(s): Are you a U.S. Citizen? Do you have a Master's degree in Regulatory Affairs or an engineering field? Do you have at least 6 years of medical-device technical writing, labeling development or technical communications experience? Have you created or revised medical-device Instructions for Use (IFUs)? Have you created labeling or packaging artwork files using Adobe InDesign and Adobe Illustrator? Do you have working knowledge of

FDA, EU MDR, UDI, ISO

20417 and

ISO 15223

labeling requirements? Have you supported labeling change orders, design controls, traceability or verification documentation?

Work Location:

In person