Regulatory Operations/Tech Writer

Duration 6 months 
Location: Bothell WA
Title -Regulatory Operations Specialist/Technical Writer 

o Develop compliant Technical Files which support successful approval to market
o Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance and Marketing to develop regulatory EU-MDR documents
o Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation to support medical device registrations in all global markets
o Gather and document Technical data for MDR EUDAMED UDI submissions
o Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented

o An individual with regulatory discipline as related to medical device products 
o 5+ years of experience in international and domestic regulatory submissions 
o 5+ years of experience writing and assembling technical files or design dossiers 
o 5+ years of experience in Medical Device Regulatory with experience in software quality 
o Experience with/Knowledge of: 21CFR820, ISO13485:2016, euMDD/euMDR, ISO14971 
o Experience in associated regulations relevant to labeling and use of international symbols 
o Knowledge of basic regulatory requirements for CE marking and UDI 
o Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape 
o Ability to work nimbly, innovative approach to problem solving 
o Ability to work with international cultures 
o Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment 
o Interest in and passion for the medical device industry, bringing innovation to market 
o Effective working in multidisciplinary teams 
o Good communication skills, written and verbal 
o Additional preferred Qualifications: 
• Ultrasound product experience

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