R&D Technical Writing Analyst
Remote
Pay: $38.66/hr. - $45.33/hr.
Duration: 12+ months, Contract, W-2
Our leading medical technology client is seeking an R&D Technical Writer to support a variety of content development and labeling initiatives for R&D and manufacturing defibrillators.
Duties:
• Develop content for a variety of complex medical devices to provide accurate information that is compliant with FDA, MDR, and additional requirements.
• Creating, updating, and maintaining product documentation and labeling assets for both new product development and sustaining engineering projects.
• Primary focus on the remediation of IFUs and labels to latest EU MDR regulations and standards, CE Mark removal, and activities supporting product lifecycle management.
• Leads redline creation in Adobe.
• Leads IFU updates within DITA xml & content management platform (preferred experience: Arbortext/Windchill).
• Leads label updates within labeling design system (preferred experience: Prisym GLS).
• Leads change control activities in PLM system (preferred experience: Oracle Agile).
• Participate in NPD and sustaining product meetings to provide insights on best quality outcomes for instructional material strategies and resolve related challenges.
• Conceptualize graphical elements (tables, charts, illustrations, etc.) that support instructional information. Collaborate with label/marking designers and assist with product label updates.
Qualifications:
• Bachelor's degree & 2+ years of experience in a medical device, pharmaceutical, or similarly regulated environment
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.