SR. TECHNICAL WRITER - HYBRID

Title: Sr. Technical Writer - Hybrid

Mandatory skills:

Technical Writing
medical device development, FDA, ISO
electronic document management software, hardware, software, reagents
Office, Adobe Acrobat, R&D, Research and Development, Regulatory Affairs, Quality Assurance
change requests, content management systems, change management, documentation requirements
Quality Management System, Product Development, Design Control Process, Change Control
technical documentation, organizational standards, standard operating procedure, SOP, Good Document practices, GDP
project plan, design specifications, study protocols, study reports, verification, validation reports, user manuals, labeling

Description:

The Sr. technical Writer will be responsible for creating and managing documentation for the Research and Development department. This position requires a thorough understanding of medical device development processes, documentation requirements and regulatory compliance. The technical Writer will work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance, to ensure accurate and timely documentation is produced.

Primary Duties:

Develop and maintain technical documentation that meets organizational standards, including but not limited to, standard operating procedures, procedures, design specifications, study protocols, study reports, verification and validation reports, instruction for use and user manuals.
Coordinates change requests within change management process for R&D (change in specifications, labeling, SOP)
Reviews and audits other technical publications deliverables and consistently delivers quality documentation.
As regulations change and quality systems are merged/aligned, execute the creation/refinement of documentation.
Creates end-user regulatory complaint product labeling.
Contributes to new product development and design change activities in the areas of labeling design/release, technical writing, development of artwork/images and development.
Collaborates with cross-functional teams to gather information and ensure documentation is accurate, complete, and consistent.
Manages the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
Ensures documentation is up-to date, accurate and accessible to all stakeholders.
Assists in development and implementation of documentation standards, policies and procedures.
Provides weekly summary of activities, creates project plans for tasks assigned, prioritizes, and effectively communicate updates to customers.
Follows Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training.

Knowledge, Experience, Skills:

Bachelor's degree or Master's in engineering, Science, or a related field.
3-5 years of experience in technical writing for medical device development of complex systems including hardware, software, and reagents.
Experience working in a regulated industry such as FDA or ISO.
Experience with electronic document management software (Livelink or similar) for tracking and processing document change requests.
Experience with Quality Management System.
Experience with Product Development and Design Control Processes.
Proficient in documentation tools such as Office, Adobe Acrobat and content management systems.
Excellent written and verbal communication skills with the ability to effectively communicate technical information to a variety of audiences.
Strong attention to detail and accuracy.
Ability to work collaboratively in a cross-functional team environment.
Ability to prioritize and manage multiple projects simultaneously.

Notes:

Fulltime Onsite, can be hybrid 2 days a week after full training/manager approval

VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at for any complaints, comments and suggestions.

Contact Details :

Account co-ordinator: Sridharan M, Phone No : ext :292, Email:

VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
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