Hiring: Senior Director, Global Compliance and Strategy Company: Dassault Systèmes Location: New York, United States Job Posted Time: 2026-09-11 12:51:42 Employment Type: Remote Target Skills & Keywords : Manufacturing Execution Systems, Risk Management About the job Experience: •10+ years of experience in regulatory affairs and/or quality management in the life sciences industry (experience with a regulatory agency preferred, but not required) Required Skills: •Serve as trusted advisor to executive leadership on matters of regulatory risk and business-impacting compliance decisions. •Own regulatory strategy and compliance for healthcare technology products across U.S. and European markets, ensuring alignment with evolving regulatory expectations. •Be an internal escalation point for novel or complex regulatory questions raised by customers, commercial teams and executive leadership, providing well-reasoned and decisive guidance. •Manage and improve our QMS to ensure that it is compliant with regulatory requirements and reflects Medidata's best practices. •Establish and maintain quality processes that support software development, AI-enabled technologies, validation, risk management, and post-market activities. •Conduct regulatory impact assessments for new products, features, and geographic expansions. •Partner with Engineering and Product teams to review design controls, product documentation, and other validation documents to ensure that products meet regulatory expectations. •Monitor FDA, EMA, ICH, and other global regulatory bodies for proposed rules, final guidance, enforcement trends, and policy shifts relevant to Medidata's business. Qualifications: •Demonstrated experience developing and communicating strategy at the executive or board level •Expertise in FDA, ICH guidelines, and other relevant global regulatory frameworks; ability to monitor, interpret, and operationalize evolving guidance from regulatory agencies •Demonstrated experience managing a QMS •As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. •The salary range for positions that will be physically based in the NYC Metro Area is $157,500 - $210,000. •We will accept applications on an ongoing basis until we fill the position. Compensation: •$157,500 - $210,000 / year •Flexible work environment (work from home / hybrid options) •Listen to our latest podcast, from Dreamers to Disruptors, and follow us at @Medidata Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!