Principal Program Manager, Health and AI

Principal Program Manager

We are currently seeking an experienced Principal Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help manage the development and implementation process of the Oracle Health Medical Device Compliance Program. You will drive the definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. Work is non-routine and very complex, involving the application of advanced technical and business skills in this area of specialization. Leading contributor individually and as a team member, providing direction to others. This role requires experiences working within or alongside product management, leadership skills, and strong business judgment. This position is critical to the success of Oracle for all customers within our global markets which continue to expand as well as efforts tied to Next Gen. All markets impacted and Next Gen success are crucial to the company; not having the best candidate and person running the program could add more risk to the program than we are facing today. The criticality of this position requires avoiding errors in decision making and providing thoughtful recommendations throughout the program lifecycle. The job requires the successful delivery to ensure we do not negatively impact the markets noted nor our reputation in the market. The Principal Program Manager must become a trusted advisor to the contributing organizations (internally and externally), ensure consistency and quality of deliverables, drive our overall strategy, overcome challenges, and meet business goals, and use leading practices for successful Oracle Health products and technology and operations. The must spearhead our ongoing engagement, technical advisement, and relationship management. You should be passionate about delivering services to customers while also possessing a deep understanding of strategic business objectives. The expectations of this position include work independently and with other team members to define the program's strategic plans, timelines that cross multiple LOBs and other Oracle organizations, and create and operationalize a clear communication plan for this work. You will be expected to independently work through mitigation options for program-level risks identified in any area of the program (Oracle Health and all other Oracle organizations noted above). You will work to directly mitigate the risks with those areas impacted.

Responsibilities

Help manage the development and implementation efforts for the Oracle Health Medical Device Compliance Program. Success for this position includes the following scope :

• Oversee the completion efforts for our technical documentation requirements for UK and EU medical device conformity assessments.
• Ensure the proper execution for our program strategy for all products in scope, including leading technical discussions with all Oracle Health LOBs to solidify the scope for each established workflow. Each workflow includes input and strategy sessions for multiple product areas and LOBs.
• Participate in complex conversations to analyze requirements set by notifying bodies.
• Driving required efforts for clinical research on devices within scope and ensure Oracle Health can prove that the device meets regulatory requirements.
• Compiling and tracking the successful delivery of all technical documentation, ensuring it meets the requirements for our notifying bodies and ensuring every device meets safety and performance requirements.
• Collaborate with cross-functional teams to drive requirements to instill / mechanize the operational bar into existing tooling.
• Establish and communicate clear guidelines and standards for measuring the operational bar, ensuring alignment with our strategy.
• Collaborate with stakeholders across the organization, leveraging your expertise to drive the successful adoption and adherence to an operational bar.
• Utilize your program management skills to coordinate complex initiatives, ensuring milestones are met, and objectives are achieved within established timelines.

7+ years' experience developing and implementing strategy