Senior Manager/Director of Regulatory Affairs

Position SummaryWe are working with a small, innovative medical device company that is scaling its regulatory capabilities to support a growing product portfolio and pipeline, and is looking to hire in both New York and California.The Senior Manager / Associate Director of Regulatory Affairs will be responsible for leading regulatory strategy and execution across the company’s products, ensuring compliance with global regulatory requirements while supporting development and commercialisation activities.Key ResponsibilitiesDevelop and execute regulatory strategies for US (FDA) and international markets (EU MDR, Canada & more)Lead preparation, review, and submission of regulatory filingsServe as a key interface with regulatory authorities, supporting or leading interactions depending on levelProvide regulatory guidance to cross-functional teams including R&D, Clinical, Quality, and CommercialEnsure compliance with applicable regulations and standards (21 CFR Part 820, ISO 13485)Support product lifecycle activities including design changes, labelling, and post-market requirementsMonitor evolving regulatory requirements and assess impact on company strategyContribute to or lead regulatory aspects of audits, inspections, and quality system activitiesManage external consultants and regulatory partnersAdditional Associate Director-Level Responsibilities:Partner with Senior Director of RAQA to define and drive global regulatory strategyLead regulatory planning across pipeline and commercial programsProvide leadership, mentorship, and potential management of regulatory staffOwn regulatory input into business development, due diligence, and strategic initiativesIdentify and mitigate regulatory risks at a portfolio levelQualificationsBachelor’s degree in life sciences, engineering or related field (advanced degree preferred)Senior Manager: 8–12+ years of regulatory affairs experience in medical devicesAssociate Director: 12–18+ years of regulatory affairs experience with demonstrated strategic leadershipStrong experience with FDA submissions (510(k), De Novo, PMA) - IDE experience preferred for Associate Director levelExtensive knowledge of FDA and international regulatory frameworksRAC certification is a plusKey CompetenciesAbility to operate both strategically and tactically based on business needsStrong project management and execution capabilitiesExcellent communication and cross-functional collaboration skillsLeadership capability (direct or indirect), with ability to influence without authorityComfort working in a fast-paced, resource-constrained environmentStrong problem-solving skills and attention to detail