Job Description:

We are currently seeking an experienced Global Regulatory Product Manager and Regulatory Technical Compliance Specialist to build and lead a new internal initiative within Oracle Health.In this critical role, you will drive 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.  You will be specifically responsible for the successful management of the program to achieve company-wide objectives and goals for all requirements within Oracle Health and regulatory compliance efforts required by a Notifying Body. A Notified Body review addresses two limbs: (1) conformity of the manufacturer’s ISO 13485 quality management system (QMS) with additional EU MDR requirements; and (2) compliance of technical documentation with EU MDR requirements (particularly the parts demonstrating the safety and performance of the device). You will need to have at least 12-15 years of experience in program management as well as regulatory specialist knowledge and experience within the healthcare and IT industries. This job requires broad expertise and knowledge of both Healthcare IT and more importantly, our regulatory landscape which increases the program’s complexity. The position will use those skills and experiences to successfully achieve the goals outlined. You should be able to strategically create goals for the organization to ensure a successful delivery of our global regulatory program efforts for Oracle Health. The position requires the ability to lead technical meetings with all levels of employees (M2-M7+) and across every LOB within Oracle Health. It also requires someone to strategize and lead end-to-end program committee meetings with all LOBs within Oracle Health as well as the following Oracle organizations: Legal, Regulatory & Compliance, Finance, Global Business Practice, and our Customer-Facing Organizations (Consulting, Support, et al).

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.

Global Regulatory Product Manager and Regulatory Technical Compliance Specialist 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 analyzing critical regulations and requirements to determine the best solution for the program. You will need to work independently 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. Additionally, the position will require regular M7+ engagement across all LOBs within Oracle Health as well as outside Oracle organization contributing to this work. This will require reporting regularly to M7+ leadership in both written and verbal communication, consistent reporting, and other program essentials. Some communications will require visibility up to and including T.K. Anand, Seema Verma, Stuart Levy, Safra Catz, and Larry Ellison.