Oracle

Specific Responsibilities include:

• Lead the health and life sciences regulatory strategy in the region, including regular participation and leadership of Health meetings to update, advise, and educate Oracle leaders on health regulatory requirements and policy initiatives.
• Work with the compliance and business teams to ensure required healthcare and life sciences training is provided to enable Oracle’s regulatory strategies.
• Participate in Oracle’s Health Compliance Board and ensure appropriate governance.
• Strategies are in place to address existing and new regulatory requirements and legislative proposals.
• Lead and work with the health and life sciences regulatory strategy team to monitor, assess, and advise on relevant regulatory developments and their impact on Oracle Health and Life Sciences products and services.
• Monitor legislative developments and proposals impacting Oracle Health and Life Sciences products and services and design and implement a policy plan in coordination with Oracle’s leadership and government affairs teams.
• Participate in and represent Oracle with various regulatory bodies and agencies to implement Oracle’s health policy initiatives in JAPAC.
• Design and implement regulatory strategies to ensure compliance with software as a medical devices regulations in jurisdictions in the region.
• Formulate strategies to implement patient safety priorities with product teams, leadership, customers, and regulatory authorities as appropriate and promote a patient safety culture.
• Participate in developing regulatory strategies for evolving AI/ML regulations relevant to health and life sciences industries and participate in and comment on various public policy initiatives relating to AI/ML.
• Design and implement regulatory strategies to ensure compliance with ONC CHERT standards, anti-kickback statute, fraud, waste and abuse laws, and other relevant certifications and standards.
• Lead and participate in developing a corporate-wide regulatory framework and program to meet the needs of Oracle customers subject to strict regulatory requirements with a focus on the healthcare/health science industries.
• Collaborate cross-functionally with other teams, including internal development, cloud operations, compliance, security, business practices, marketing, and sales teams, to help progress the regulatory program goals and initiatives.
• Maintain high credibility, independence, integrity, confidentiality, and trust.
• Able to influence the ecosystem and be considered as the key stakeholder for internal and external network, positioned as a real Trusted Advisor. 

What you’ll bring

• We are seeking a J.D. (or a Regulatory Attorney) with 5 to 10 years of legal experience in healthcare or life sciences. Minimum qualifications include an advanced degree with relevant work experience in healthcare or life sciences regulatory work.
• Knowledge of healthcare tech and life sciences regulatory requirements in Australia (eventually JAPAC).
• Strong domain in Medical Devices / Medical Devices Software Regulation. 
• Professional demeanor, confidence, and innovation with the ability to effectively communicate with senior executives and clients.
• Excellent writing, analysis, negotiation, and partnership skills.
• Problem solver (not just an issue spotter) with a creative, innovative approach and 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.

Career Level - IC6

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Disclaimer:

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.

• Which includes being a United States Affirmative Action Employer