Legal Director, Global Regulatory

Support RWD governance and compliance activities, ensuring adherence to applicable laws, regulations, global standards, and internal policies. Provide legal support to the RWD director and Corporate Medical Affairs on strategic initiatives and operational matters. Advise on FDA, EU MDR, cybersecurity laws including HITECH and SOC 2, anti-kickback statutes, FCPA, and other global regulations impacting medical devices. Monitor evolving laws, regulations, and guidance impacting medical devices and RWE globally. Deliver training and guidance to internal stakeholders on compliance-related topics. Provide proactive legal guidance and recommend process improvements to reduce regulatory risk exposure. Juris Doctor degree and admission to practice law in at least one US state Minimum of 8 years' experience in legal practice in or supporting the medical device industry Minimum of 2 years' experience in the regulatory and quality Deep understanding of FDA, EU MDR, and other global regulatory frameworks. Demonstrated experience advising on complex regulatory and compliance issues in a global environment. Excellent drafting, negotiation, and communication skills. Ability to manage complex projects and deliver practical, business-oriented legal advice. Ability to travel up to 10% globally Experience advising on real-world evidence and real-world data programs. Demonstrated ability to influence and build relationships across global functions. Strong organizational and prioritization skills in a fast-paced environment. High integrity and demonstrated commitment to compliance.