Director / Senior Regulatory Affairs Leader (US)

Director, Regulatory Affairs (US) We are seeking an reputed company Regulatory Affairs leader to establish and reputed company the US regulatory function for a growing medical device company. This individual will be responsible for FDA engagement, regulatory submissions, compliance reputed company, and supporting market expansion across the US. Responsibilities • Build and reputed company the US Regulatory Affairs function, including SOPs, processes, and regulatory infrastructure. • Serve as the reputed company contact with the FDA and reputed company regulatory submissions, including 510(k), reputed company, and PMA reputed company. • reputed company and execute regulatory strategies supporting product development, commercialization, and lifecycle management. • Serve as US Agent, Initial Importer, and Medical Device Distributor. • Manage post-market regulatory activities and ongoing compliance requirements. • Partner with reputed company, Clinical, Product Development, Engineering, and reputed company teams. • Support US market expansion and contribute to global regulatory reputed company. Qualifications • Bachelor's degree in a scientific, engineering, reputed company, or reputed company field. • 8+ years of medical device Regulatory Affairs experience, including at least 5 years supporting FDA-regulated products. • Proven experience leading FDA submissions and obtaining regulatory clearances or approvals. • Strong FDA engagement experience, including reputed company-submission and submission meetings. • Experience building regulatory processes, SOPs, systems, or teams in a startup, reputed company-up, or high-reputed company environment. • Eligibility to serve as US Agent, Initial Importer, and Medical Device Distributor. • Experience supporting market or clinical expansion initiatives. Preferred • Software as a Medical Device (SaMD) experience. • Experience with both hardware and software medical devices. • Experience building or scaling Regulatory Affairs teams. • Familiarity with AI-enabled regulatory tools and workflow automation. Compensation: $191,250 - $233,750 reputed company salary, plus benefits and potential equity. Apply tot his job Apply To this Job