Job Description About the role At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global organizations that engage deeply in this space requires a legal/business leader who is deeply steeped in the levers, both public and private that impact this industry. To remain competitive in this rapidly changing landscape, organizations require a legal/business leader who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for a legal expert in the software as a medical device and healthcare regulatory space, who will be leading decisions and actions that concern this broad array of risks and opportunities in the region. With his/her regulatory expertise and business acumen, he/she will play a pivotal role in driving Oracle's success and competitiveness in the healthcare and life sciences sector. About the business Oracle's Healthcare and Life Sciences business provides industry-specific software and solutions to healthcare providers, payers, pharmaceutical, and medical device companies, and clinical research organizations. It offers a range of products and services, including cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. The business aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. By leveraging Oracle's technology and expertise, healthcare and life science organizations can streamline their operations, gain insights from data, and make more informed decisions. Oracle also enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. With a focus on digital transformation, Oracle's Healthcare and Life Sciences business empowers the industry to embrace modern technologies and improve overall healthcare delivery. Career Level - M5 Responsibilities What you'll do As Senior Director, EMEA Health and Life Sciences, you will oversee Oracle's health and life sciences regulatory strategy and implementation in the region, working closely with the health and medical device regulatory teams and the Health and Life Sciences Chief Health Compliance Officer and compliance teams, along with product, sales, and consulting teams to develop and implement regulatory strategies to address local regulations related to healthcare tech and life sciences products, emphasizing patient safety as a priority. You will regularly report to Oracle leadership on health and life sciences regulatory strategies and implementation plans, work to mitigate risks appropriately, and escalate key risks to senior leadership for action. Additionally, you will work with product, sales, and consulting teams to understand business strategy. Specific Responsibilities include: - Lead the health and life sciences regulatory strategy in the region, including regular participation in and leadership of Health meetings to update, advise, and educate Oracle leaders on health regulatory requirements and policy initiatives. - Lead counsel for the region on legal regulatory issues impacting our customers' use of Oracle products with a focus on electronic health records technologies, artificial intelligence and machine learning, software as a medical device, life sciences clinical research, real world data, privacy and security, and European Health Data Space. - Advise on the regulatory implications of commercial transactions to enable the fast and efficient completion of commercial transactions in a manner that is viewed positively by our customers and partners. - Work with the health and life sciences regulatory affairs team to monitor, assess, and advise on relevant regulatory developments and their impact on Oracle Health and Life Sciences products and services. - Participate in and represent Oracle with various regulatory bodies and agencies to implement Oracle's health policy initiatives in the EMEA region. - Design and implement regulatory strategies to ensure compliance with software as a medical devices regulations in jurisdictions in the region. - Formulate strategies to implement patient safety priorities with product teams, leadership, customers, and regulatory authorities as appropriate and promote a patient safety culture. - Participate in developing regulatory strategies for evolving AI/ML regulations relevant to health and life sciences industries and participate in and comment on various public policy initiatives relating to AI/ML. - Design and implement regulatory strategies to ensure compliance with EHDS, GDPR, fraud and abuse laws, and other relevant legal regulatory requirements in the region. - Lead and participate in developing a corporate-wide regulatory framework and program to meet the needs of Oracle customers subject to strict regulatory requirements with a focus on the healthcare/health science industries. - Input into policy initiatives in the health and life sciences regulatory space in the EMEA region and globally. - Collaborate cross-functionally with other teams, including internal product development, cloud operations, compliance, security, business practices, marketing, and sales teams, to help progress the regulatory program goals and initiatives. - Maintain high credibility, independence, integrity, confidentiality, and trust. What you'll bring - We are seeking a J.D. (or a Regulatory Attorney) with 15 years of legal experience in healthcare or life sciences. Minimum qualifications include an advanced degree with 10 years of relevant work experience in healthcare or life sciences regulatory work. - Knowledge of healthcare tech and life sciences regulatory requirements in Europe. - Strong domain in Medical Devices / Medical Devices Software Regulation. - Professional demeanor, confidence, and innovation with the ability to effectively communicate with senior executives and clients. - Excellent writing, analysis, negotiation, and partnership skills. - Problem solver (not just an issue spotter) with a creative, innovative approach and strong decision-making abilities. - Outstanding project management and interpersonal skills. - Exceptional business orientation and ability to balance legal considerations with commercial priorities. - Ability to perform in a fast-paced and continually evolving business environment. Leadership competencies - Performance, drive, and execution You'll deliver value and shape a performance-driven culture while ensuring accountability and communicating expectations. - CollaborationYou understand and promote the value of collaboration and inclusivity and can align strategic aims with organizational goals - Communicating for impact You inspire confidence by championing a clear understanding and support of organizational strategy and objectives. - Inspirational leadership You build a reputation for strategy by inspiring and empowering others while showing leadership internally and externally. - Competitive edge You anticipate changes in customer needs and seize opportunities to build value, encourage innovation, and meet objectives. - Change agility You're comfortable with leading strategic change and adapting to the market. Inspiring creativity and entrepreneurial thinking is second nature. - Mastering complexity You think long-term in your decisions, support solutions to complex problems, and encourage accountability in problem solving. Education A Law Degree is required for this role. At Oracle, we don't just respect differences-we celebrate them. We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities. That's why we're committed to creating a workplace where all kinds of people can do their best work. It's when everyone's voice is heard and valued that we're inspired to go beyond what's been done before. We expressly encourage disabled candidates to apply for this position. Please therefore feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX. Directs and ensures the implementation of operational policies through subordinate managers Interacts internally and externally with executive management involving negotiation of difficult matters to influence policy. Functional expertise and broad company knowledge. 12 years related experience. Completed law degree and member of bar association in relevant jurisdictions. Ability to travel as needed. About Us As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's problems. True innovation starts with diverse perspectives and various abilities and backgrounds. When everyone's voice is heard, we're inspired to go beyond what's been done before. It's why we're committed to expanding our inclusive workforce that promotes diverse insights and perspectives. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40 years of change by operating with integrity. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer a highly competitive suite of employee benefits designed on the principles of parity and consistency. We put our people first with flexible medical, life insurance and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by calling 1 888 404 2494, option one. Disclaimer: Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law. - Which includes being a United States Affirmative Action Employer