Technical Writer - Regulatory Operations

Job Title – Regulatory Operations Specialist/Technical Writer 
 
Job Location – Bothell WA
 
Length – Contract (6 Months+)
 
Responsibilities: 
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 
 
Skills:
 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
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com

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