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