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Regulatory Affairs Associate

Company: Alten Calsoft Labs
Location: Sunnyvale
Posted on: March 27, 2020

Job Description:

Job Title: Regulatory Affairs AssociateDuration: 12 Months (Contract)Location: Sunnyvale, CADepartment: Global Distribution RA/QAReports To: Global Distribution RA ManagerPrimary Function of Position:The Regulatory Affairs Associate within the Global Distribution RA/QA team will assist with projects and duties to support the indirect (distributor) regions. Primary responsibilities include supporting regulatory submissions and related processes as well as some QA functions as needed.Roles and Responsibilities:Coordinate document preparation to support various registrations, certifications and license applicationsReview product labeling, records, design documents, etc. for submissions and compliance with applicable regulations and policiesCollect all necessary supporting documents for submissionsPrepare additional information or responses as neededKeep all necessary records for change notificationsMaintain electronic libraries of applicable standards, test reports, certificates, licenses, declaration of conformities, and other documentation to support regulatory submissionsMaintain registration databases and project statusPerform support activities included but not limited toMaintain a list of Purchase Requests and Purchase OrdersCreate RAO/MCOs/ECOs as neededAssist with research and analysis of regulationsAPL and Registration Approval ProcessPerform other duties as requiredParticipate as the Global Distribution RA/QA representative on other projects as requested or neededSkill/Job RequirementsMinimum requirements in order to adequately perform the responsibilities of this position:Education:B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferredNon-technical degree with equivalent complex medical device experience acceptableExperience/Skills:2-4 years relevant experience working in a medical device company, regulated environment or equivalentRegulatory submission preparation experience a plusQuality or regulatory affairs experience in a medical device company a plusStrong verbal and written communication skillsSelf-motivated and willingness to help othersAbility to work in a fast-paced and dynamic environmentAbility to handle multiple projects and deadlines simultaneously in a team settingExperience with global regulationsIndependent thinker, willing to present alternative conclusions or inferencesStrong computer skills, particularly with Excel and the ability to learn new applications, Microsoft Office Suite, SAP & Agile experience preferredGood interpersonal skills and able to work well with cross-functional teamsSolid attention to detail, organization skills and ability to multi-task

Keywords: Alten Calsoft Labs, Sunnyvale , Regulatory Affairs Associate, Other , Sunnyvale, California

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