Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWe're hiring a Senior Regulatory Affairs Specialist to support U.S. and global regulatory submissions for medical devices and partner with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.Key ResponsibilitiesPrepare and support submissions including IDEs, 510(k)s, CE Technical Documentation, UKCA, and global registrationsMaintain regulatory approvals and submission documentationReview design control documents, labeling, and quality system proceduresSupport regulatory agency interactions and responsesCollaborate with R&D, Quality, Clinical, and Marketing teamsMonitor regulatory changes and competitor activitiesAssist with SOPs, process improvements, and post-market activitiesQualificationsBachelor's degree in a scientific or engineering discipline4+ years of medical device Regulatory Affairs experienceExperience with FDA and international regulatory submissionsKnowledge of FDA regulations, Design Controls, ISO 13485, and global medical device requirementsStrong communication, organization, and project management skillsAdditional InformationHybrid role based in Alameda, CA10-30% travel as neededNo current or future visa sponsorship availableEqual Opportunity Employer#RegulatoryAffairs #MedicalDevices #FDA #510k #MedTech #BayAreaJobs #AlamedaCA #Hiring #EPMScientific