Regulatory Affairs Specialist

Regulatory Affairs SpecialistLHH Recruitment Solutions is seeking a Regulatory Affairs Specialist for a minimum 6-month remote contract opportunity. This position is open to candidates residing in California who have prior experience in the medical device industry. The ideal candidate will have a strong understanding of regulatory requirements, medical device compliance, and regulatory documentation.

This role offers an hourly pay range of $38-$56 per hour, depending on experience, with a Monday-Friday schedule from 8:00 AM to 5:00 PM PST.Responsibilities:Prepare, review, and maintain regulatory submissions and documentation for medical devices in accordance with applicable FDA requirementsSupport regulatory compliance activities throughout the medical device product lifecycleReview product documentation, labeling, and technical files for accuracy and compliance with regulatory standardsMonitor changes to FDA regulations and other applicable medical device regulatory requirementsCollaborate with Quality Assurance, Research and Development, and other cross-functional teams to support regulatory initiativesAssist with regulatory audits, inspections, and responses to regulatory inquiriesMaintain organized regulatory records and ensure documentation meets internal quality standardsSupport regulatory strategy and provide guidance on compliance requirements for new and existing productsQualifications:Previous regulatory affairs experience within the medical device industry is requiredKnowledge of FDA regulations and medical device regulatory requirementsStrong documentation, organizational, and communication skillsAbility to manage multiple priorities and meet deadlines in a remote environmentMust reside in California and be available to work Monday-Friday, 8:00 AM-5:00 PM PSTAssignment Details:Contract roleRemoteLocated in San DiegoCompensation: $38.00 - $56.00 per hour DOEIf you meet the qualifications and are interested in this opportunity, please apply now — we are conducting interviews immediately!