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 policy 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 policy leaders who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for a med-tech expert with experience in both SaMD and the use of AI in the life sciences industry to play a leadership role evaluating and influencing policy. This role will play a pivotal role in driving Oracle's success and competitiveness in the healthcare and life sciences sector.
As Global Medical Device & Life Sciences Policy Director, you will lead regulatory policy efforts impacting our global AI-enabled, Cloud-native software applications used in clinical settings (Medical device and non-Medical Device) as well as our life sciences product offerings. We are seeking an experienced thought leader who is well respected and influential in the med-tech industry. You will establish strong partnerships with business teams to understand their products and policy needs as well as work cross functionally across the government affairs and legal and compliance group. You will track and evaluate regulatory developments impacting the company and lead our response to regulatory developments. You will also participate in trade association meetings and other thought leadership opportunities. The role is global in scope, but will involve collaboration with Medical Device and Life Sciences regulatory affairs, legal, and policy teams across the globe.
We are seeking a leader who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. Our team members are dedicated to excellence in their work, have instinctively good judgment and impeccable integrity. For this role we are seeking a leader who is strategic, collaborative, and a creative problem-solver.
About the Business:
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. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, pharmacovigilance tools, 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.
Internal Responsibilities
What You’ll Do:
You will be responsible for monitoring and analyzing regulatory developments impacting Oracle’s business from the Food & Drug Administration and similar global regulators. This role involves in-depth knowledge of medical device regulations as well as regulations and policy impacting the life science industry’s use of AI and technology.
- Monitor, analyze and report on SaMD regulations and policy and help assess impact to Oracle Health products and services.
- Monitor and analyze regulations and guidance impacting use of real-world evidence, data analytics, AI in drug development, and other issues impacting the use of technology in the life sciences industry.
- Develop and maintain relationships with IMDRF, U.S. Food & Drug Administration and other global regulators.
- Participate actively in trade association meetings and committees.
- Participate in conferences and other events and engage in opportunities for thought leadership, such as speaking and writing opportunities.
- Collaborate with medical device regulatory affairs, legal, life sciences regulatory policy, and government affairs teams to develop policy positions and coordinate advocacy efforts.
- Lead strategic policy advocacy efforts with respect to the U.S. Food and Drug Administration and coordinate efforts with IMDRF other similar global regulators.
- Develop executive summaries and briefings.
Preferred Qualifications:
- Bachelor's degree - advanced degree preferred.
A regulatory policy expert with 15+ years of experience with med-tech and/or software as a medical device.
Experience working at the U.S. Food & Drug Administration preferred.
Experience with regulatory policy at the intersection of technology and the life sciences.
Experience with the evolving regulatory landscape impacting AI and ML.
Professional, confident demeanor with ability to effectively counsel and brief senior executives.
Excellent reputation in the med-tech industry and with regulators.
Excellent writing, communication, analysis, and partnership skills.
Problem solver (not just an issue spotter) with creative and innovative approach along with strong decision-making abilities.
Ability to perform in a fast-paced and continually evolving business environment.
#LI-SP1
External Responsibilities
What You’ll Do:
You will be responsible for monitoring and analyzing regulatory developments impacting Oracle’s business from the Food & Drug Administration and similar global regulators. This role involves in-depth knowledge of medical device regulations as well as regulations and policy impacting the life science industry’s use of AI and technology.
- Monitor, analyze and report on SaMD regulations and policy and help assess impact to Oracle Health products and services.
- Monitor and analyze regulations and guidance impacting use of real-world evidence, data analytics, AI in drug development, and other issues impacting the use of technology in the life sciences industry.
- Develop and maintain relationships with IMDRF, U.S. Food & Drug Administration and other global regulators.
- Participate actively in trade association meetings and committees.
- Participate in conferences and other events and engage in opportunities for thought leadership, such as speaking and writing opportunities.
- Collaborate with medical device regulatory affairs, legal, life sciences regulatory policy, and government affairs teams to develop policy positions and coordinate advocacy efforts.
- Lead strategic policy advocacy efforts with respect to the U.S. Food and Drug Administration and coordinate efforts with IMDRF other similar global regulators.
- Develop executive summaries and briefings.
Preferred Qualifications:
- Bachelor's degree - advanced degree preferred.
A regulatory policy expert with 15+ years of experience with med-tech and/or software as a medical device.
Experience working at the U.S. Food & Drug Administration preferred.
Experience with regulatory policy at the intersection of technology and the life sciences.
Experience with the evolving regulatory landscape impacting AI and ML.
Professional, confident demeanor with ability to effectively counsel and brief senior executives.
Excellent reputation in the med-tech industry and with regulators.
Excellent writing, communication, analysis, and partnership skills.
Problem solver (not just an issue spotter) with creative and innovative approach along with strong decision-making abilities.
Ability to perform in a fast-paced and continually evolving business environment.
#LI-SP1
