ekohealth - Director, Global Regulatory Affairs & Intelligence

• Bachelor's degree in a STEM field (Engineering, Life Sciences, or related discipline); advanced degree preferred • 10+ years of progressive regulatory affairs experience with Class II medical devices and Software as a Medical Device (SaMD), including hands-on submission authorship and successful FDA and international approvals (must provide specific K numbers) • Deep expertise in global regulatory frameworks (FDA 510(k)/De Novo, EU MDR, ISO 13485, MDSAP) and demonstrated ability to navigate complex, multi-jurisdictional pathways • Proven track record managing regulatory authority interactions, including pre-submission meetings, deficiency responses, and regulatory inspections with favorable outcomes • Strategic regulatory intelligence capabilities with ability to translate emerging requirements (AI/ML regulations, cybersecurity guidance) into actionable business recommendations • Experience leading small but mighty regulatory teams in fast-paced, innovation-driven environments with rapidly evolving product portfolios • Proficiency with regulatory information management systems, quality management software (e.g., Veeva Vault, MasterControl, Greenlight Guru), and submission platforms (eSTAR, EUDAMED) • Strong communication, organizational, and problem-solving skills with ability to influence cross-functional stakeholders and present complex regulatory strategy to executive leadership • Great track record of successful teaming and contributing meaningfully to company culture • Ability to perform the essential functions of the role with or without reasonable accommodation • Advanced degree (MS, PhD, MBA, or RAC) in a relevant scientific, engineering, or regulatory discipline • Experience with AI/ML-enabled medical devices and familiarity with FDA's Software Pre-Cert Program, AI/ML guidance, and algorithm change protocols • Regulatory Affairs Certification (RAC) from RAPS or equivalent professional credential • Direct experience in digital health, cardiovascular diagnostics, or acoustic/sensor-based medical technologies • Track record securing breakthrough device designations, De Novo classifications, or novel regulatory pathways for first-in-class innovations • Experience navigating reimbursement considerations and engaging with health economics teams to support regulatory strategy and claims development • Background in early-stage or high-growth medtech startups with demonstrated ability to build regulatory infrastructure from the ground up • Experience serving as or managing the requirements for a Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745 • Experience overseeing Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP) to strategically align clinical evidence with global regulatory claims and maximize competitive positioning.