Location:
This is a hybrid remote/in-office role - NYCMedidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week following Company policy. About our Company: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating over 25 years of ground-breaking technological innovation across more than 38,000 trials and 12 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million registered users across approximately 2,300 customers trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at. Listen to our latest podcast, from Dreamers to Disruptors, and follow us at @Medidata.
About the Team:
The Senior Director, Global Compliance & Strategy sets the strategic direction for regulatory affairs and quality management system (QMS) functions across Medidata's life sciences technology platform, and partners with executive leadership to shape how compliance informs Medidata's broader business strategy. In this role, you will sit at the intersection of product, compliance, and internal strategy, translating complex and evolving regulatory requirements into clear, executable frameworks that keep our business ahead of change. You will lead the maintenance of our QMS, serve as the internal expert on global regulatory developments, and guide product and engineering teams through design controls and risk management. A key part of this role is proactive horizon scanning; monitoring regulatory agencies, proposed rulemakings, and industry guidance to identify changes that may affect our platform, customers, or operations before they arrive and proactively working with business teams to implement necessary changes. You will lead and grow a team of experienced professionals who understand that great regulatory thinking is a competitive advantage, not just a checkbox.
Responsibilities
Regulatory Strategy and Executive Engagement:- 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. QMS Ownership & Regulatory Operations
- 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.
Regulatory Intelligence & Horizon Scanning:
Monitor FDA, EMA, ICH, and other global regulatory bodies for proposed rules, final guidance, enforcement trends, and policy shifts relevant to Medidata's business. Assess the potential impact of regulatory developments on our platform, product roadmap, AI roadmap and customer base and communicate actionable findings to executive leadership and other internal stakeholders. Translate emerging requirements into scalable internal policies, procedures, and implementation plans that proactively position the business for compliance.
Product, Engineering & AI Regulatory Advisory:
Serve as the internal regulatory expert for product development cycles advising on classification, intended use, AI governance, validation, regulatory strategy and design controls from concept through launch. Review and provide regulatory input on product roadmaps, AI-enabled features, software releases and significant design changes. Provide regulatory leadership for AI/ML-enabled capabilities, servicing as the executive-level voice on AI governance strategy across the business.
Qualifications:- 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)
- Experience with direct management and development of an internal team of compliance and regulatory affairs professionals
- 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 QMSExperience advising internal business, product and engineering teams on regulatory requirements and risk management
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. Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work.
Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides benefits, including medical, dental, life and disability insurance, 401(k) matching, family leave, flexible paid time off; and 10 paid holidays per year.
Equal Employment Opportunity:
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. We will accept applications on an ongoing basis until we fill the position.#LI-EM1#LI-Hybrid
