Senior Managing Counsel, Health and Life Sciences Americas

**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 life sciences, medical device, and healthcare regulatory space, who will be leading decisions and actions that concern a broad array of risks and opportunities. 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.

**What you’ll do**

As Senior Managing Counsel, Health and Life Sciences Americas, you will oversee Oracle’s health and life sciences regulatory legal strategy in North America and Latin American regions, working closely with the life sciences, 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 and legal strategies to address risks 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 legal risks, 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 counsel 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, AI, and other evolving regulatory areas.
• 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 and with relevant trade associations.
• Advise on software as a medical device laws and 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.
• Advise on 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.
• Advise on regulatory requirements impacting clinical research, pharmacovigilance, medical product commercialization, fraud and abuse laws, and other relevant legal regulatory requirements, as well as other legal developments relevant to the health and life sciences business lines.
• Input into policy initiatives in the health and life sciences regulatory space.
• 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 the US is required. Knowledge of Canadian health and life sciences law in addition to the US is preferred.
• Strong domain in Antikickback Statute, False Claims Act, and/or 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.