Senior Regulatory Affairs Specialist

We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy, submissions, and product lifecycle activities.This is a high-impact opportunity to work cross-functionally and contribute to product development and international market expansion.Title: Senior Regulatory Affairs Specialist (Medical Device) Location: East Bay, CASend Resumes to: kathie.calderara@LHH.comKey ResponsibilitiesDevelop and execute regulatory strategies for Class I–II medical devicesPrepare and manage submissions including FDA 510(k), EU MDR Technical Documentation, CE Mark, and global registrationsLead regulatory communications with U.S. and international agenciesSupport global product registrations across the U.S., EU, Canada, APAC, and LATAMEvaluate regulatory impact of product, design, and labeling changesConduct regulatory gap assessments and monitor evolving regulatory requirementsMaintain regulatory documentation and ensure audit readinessSupport post-market activities including MDR, vigilance reporting, and field actionsPartner closely with R&D, Quality, Clinical, and Commercial teamsQualifications8+ years of regulatory affairs experience within the medical device industryStrong experience with FDA 510(k) submissions and EU MDR / Technical DocumentationExperience supporting global regulatory activities and product registrationsKnowledge of FDA regulations, ISO 13485, ISO 14971, and global regulatory frameworksStrong project management, communication, and technical writing skillsPreferredRegulatory Affairs Certification (RAC)Experience with digital health or SaMDCandidates must be authorized to work in the U.S. without current or future sponsorship.Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacyThe Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:• The California Fair Chance Act• Los Angeles City Fair Chance Ordinance• Los Angeles County Fair Chance Ordinance for Employers• San Francisco Fair Chance Ordinance”