Senior Director/ VP, Quality and Regulatory Affairs

Job TitleSr. Director/VP, Quality and Regulatory AffairsReports toEVP of Product EngineeringAbout ExoAt Exo, we're united by one mission, to take medical imaging where you never thought it could go - everywhere. Through the power of an ultrasound ecosystem designed for the point of care, we're building a future that isn't bound by hospital walls. A future where every body can get immediate medical answers. Where care is unconstrained. Learn more about our vision at https://www.exo.inc/our-visionJob SummaryThe Senior Director/VP of Quality and Regulatory Affairs is a critical member of the leadership team, responsible for establishing and leading the company's quality and regulatory function, as well as the champion for Exo's total quality management system. This leader oversees all aspects of quality assurance, quality control, regulatory affairs, R&D quality, compliance, production/supplier quality and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations. The Senior Director/VP will work closely with Engineering, Operations, Sales, Marketing and Clinical Affairs.Job ResponsibilitiesAuthorized to act as the Regulatory Affairs representative to external regulatory agencies (ex. FDA, Notified Bodies, Competent Authorities, etc) and industry groups.Management Representative for the Quality System.Drive and cultivate a culture of quality throughout the company to ensure compliance with all applicable regulations, guidelines, and corporate standards, policies, and procedures.Develop, implement and maintain a Quality System in compliance with all applicable regulatory requirements. Establish domestic and international regulatory strategy for Exo's products and educate the organization on deliverables to achieve regulatory goals.Prepare and/or oversee FDA and International submissions which could include 510(k), De Novo, International Technical Documentation (MDR), Design Dossier, product registrations, MDRs, vigilance reporting requirements and follow-up reports.Establish strategic goals for Quality and Regulatory Affairs.Ensure that the company, its contractors and vendors are prepared for FDA and Notified Body inspections.Oversee quality in production to ensure Exo's products meet set specifications.Develop departmental budget and product cost structure, identify cost improvement opportunities, and have full budget responsibility and accountability. Review and approve departmental expense and capital budget.Lead and develop a team of regulatory and quality staff based in the U.S. and overseas.RequirementsBachelor's degree or Master's degree in a scientific discipline with at least 15 years of work experience in medical device quality and/or regulatory affairs, preferably with focus in SaMD and AI applications.Expert knowledge of FDA regulations, ISO 13485, European MDR, CMDR and other countries' medical device regulations.Experience shepherding the quality organization's contributions to successful commercialization of a product.Demonstrated experience defining the quality and regulatory strategy for hardware and software, including AI-based products.Support GDPR and ISO activities as needed. Must be a safety and compliance role model.Experience leading high-performing RAQA teams with strong people-leader skills and the ability to mentor and develop a team.Experience hosting FDA and Notified Body audits.Track record of strong personal performance combined with demonstrated ability to build and lead high-performing teams in a fast-growth environment.Demonstrated problem-solving and critical-thinking skills.Travel may be required up to 10% of the time.Compensation DisclosureSalary Range: $200,000 - $280,000The final compensation offered for this position will depend on role, level, qualifications, experience, and work location. The offered compensation may also include equity and a bonus program.BenefitsMedical + Dental + VisionLife and AD&D401(k)EAPEEOExo is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.If you require assistance or accommodation due to a disability or special need, please contact us at accomodations@exo.inc.J-18808-Ljbffr