Senior Counsel - Health & Life Sciences Legal

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 health companies requires legal leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require a legal 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 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

The Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. It offers a range of products and services, including AI/ML solutions, 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.

Responsibilities

• Lead counsel on medical device legal regulatory issues impacting our customers' use of Oracle products in the US, Canada, and Latin America, with a focus on software as a medical device, artificial intelligence and machine learning, real world data, and precision medicine.
• Advise on the appropriate regulatory standards for product qualification and classification analysis.
• Advise on the regulatory/compliance implications of and market standard terms for commercial transactions.
• Collaborate cross-functionally with other teams to help progress the regulatory and compliance programs goals and initiatives.
• Participate in pivotal initiatives to help improve Oracle’s business and to enable the fast and efficient completion of commercial transactions in a manner that is viewed positively by our customers and partners.
• Advise on changing regulatory requirements in the US, Canada, and Latin America that impact our businesses, regulatory affairs function, and quality/compliance programs.
• Input into policy initiatives in the health and life sciences regulatory space in the US, Canada, Latin America and around the globe.

Qualifications

• A JD with 10+ years of legal experience in the software as a medical device industry.
• Expertise and experience as regulatory counsel working at the intersection of technology, life sciences, and healthcare.
• Knowledge of the laws governing software as a medical device, AI/ML software, clinical research, real world data, and related topics.
• Experience advising on whether software clinical decision support products qualify as a medical device and/or qualify for enforcement discretion.
• Experience reviewing commercial transactions in the health and life sciences sectors, particularly transactions involving cutting edge technology.
• Professional demeanor, confident and innovative with ability to effectively counsel senior executives and clients.
• Excellent writing, communication, analysis, negotiation and partnership skills.
• Problem solver (not just an issue spotter) with creative and innovative approach along with 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.