Regulatory Affairs Specialist

About the JobAbout KKR ConsultingKKR Consulting partners with leading pharmaceutical and medical device organizations to deliver exceptional regulatory, quality, and engineering talent. Our focus is on building high-performing teams that drive innovation, compliance, and product excellence across the life sciences industry.Role OverviewWe’re seeking a Regulatory Affairs Specialist to support post-market regulatory activities for U.S. FDA Class III medical devices. This role will focus on maintaining compliance, assessing product and process changes, and preparing regulatory submissions in alignment with 21 CFR 814, 21 CFR 820, and ISO 13485.The ideal candidate will collaborate cross-functionally with Quality, R&D, Operations, and Marketing teams to ensure all regulatory requirements are integrated throughout the product lifecycle. This position offers an opportunity to influence both strategic and operational aspects of regulatory affairs while upholding the highest standards of safety and compliance.Key ResponsibilitiesSupport the development and implementation of regulatory strategies for post-market Class III medical devices and combination products.Evaluate design, labeling, and manufacturing changes to determine regulatory impact and required submission pathways.Prepare, review, and submit regulatory documentation, including PMA supplements, annual reports, and other post-approval submissions.Conduct regulatory risk assessments and provide recommendations to mitigate compliance risks.Maintain accurate and compliant regulatory records and databases in accordance with FDA, ISO, and internal quality system requirements.Serve as a liaison with regulatory authorities, preparing responses to inquiries and requests for information.Partner with cross-functional teams to ensure regulatory input during design changes, CAPAs, and process improvements.QualificationsBachelor’s degree in a scientific, engineering, or related discipline (or equivalent experience).Minimum 4 years of experience in the medical device industry.At least 2 years of direct experience in regulatory affairs, preferably with FDA Class III medical devices.Strong understanding of U.S. medical device regulations (21 CFR 814, 21 CFR 820) and working knowledge of ISO 13485 / ISO 9001.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).Excellent communication, analytical, and cross-functional collaboration skills.Preferred AttributesExperience interacting directly with FDA or other global regulatory authorities.Strong attention to detail and ability to manage multiple projects simultaneously.Collaborative mindset with a focus on continuous improvement and compliance excellence.