We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health. In this critical role, you will help 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 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.
Qualifications
Career Level - IC3
About Us
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.We know that true innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing an inclusive workforce that promotes opportunities for all.Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling +1 888 404 2494 in the United States.Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
