Principal Regulatory Affairs Specialist

Principal RA Specialist (9 month contract // REMOTE, Prefers hybrid in Irvine, CA):HM's Top Needs:US and EU regulatory requirements for product modifications including authorship of regulatory impact assessmentsIDE and PMA Annual Reports, IDE Supplement, PMA SupplementMDD and MDR STED updatesEducation Required: Bachelors DegreeYears’ Experience Required: 7+ years of experience authoring variable domestic and EU submissions Description: Principal RA Specialist will play a key role in sustaining the current product portfolio. Candidate has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining regulatory responsibilities include reviewing changes to ensure that regulatory requirements continue to be met, documenting “no file” decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate. Duties:Provide strategic input and guidance on regulatory requirements for product modificationsIDE and PMA Annual Reports, IDE and PMA Supplements, 510k, LTF, MDD and MDR STED updates and EU MDR submissions.Manage multiple projects and prioritize tasks to meet project schedulesInterface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilitiesRequired Skills:Minimum of 7 years of experience medical device regulatory affairs Or advanced degree with a minimum of 5 years of experience medical device regulatory affairs