Oracle

At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global organizations that engage deeply in this space requires a legal/business leader who is deeply steeped in the levers, both public and private that impact this industry. To remain competitive in this rapidly changing landscape, organizations require a legal/business leader who can navigate complex and fast-changing laws, regulations, and public policies across the globe. In this context, we are looking for a legal expert in the software as a medical device and healthcare regulatory space, who will be supporting decisions and actions that concern this broad array of risks and opportunities in the EMEA region with specific emphasis on the UK market. With his/her regulatory expertise and business acumen, this person will play a pivotal role in driving Oracle's success and competitiveness in the healthcare and life sciences sector.

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.

As Senior Counsel, EMEA Health and Life Sciences, you will help driving Oracle’s health and life sciences regulatory strategy and implementation in the region, working closely with Head of Legal, EMEA Health and Life Sciences, the health and medical device regulatory teams and the health and compliance teams, along with product, sales, and consulting teams to develop and implement regulatory strategies to address local regulations related to healthcare tech and life sciences products, emphasizing patient safety as a priority. You will regularly report to Oracle leadership on health and life sciences regulatory strategies and implementation plans, work to mitigate risks appropriately, and escalate key risks to leadership for action. Additionally, you will work with product, sales, and consulting teams to understand business strategy.

Specific Responsibilities include:

• Assist in developing and implementing the health and life sciences regulatory strategy in the region, with a particular focus on the United Kingdom, advise, and educate Oracle Life Sciences and Health senior executives on health regulatory requirements and policy initiatives.
• Advise on legal regulatory issues impacting our customers’ use of Oracle products with a focus on electronic health records technologies, artificial intelligence and machine learning, software as a medical device, life sciences clinical research, real world data, privacy and security.
• Advise on the regulatory implications of commercial transactions to enable the fast and efficient completion of commercial transactions in a manner that is viewed positively by our customers and partners.
• Work with the health and life sciences regulatory affairs team to monitor, assess, and advise on relevant regulatory developments and their impact on Oracle Health and Life Sciences products and services.
• Participate in and represent Oracle with various regulatory bodies and agencies to implement Oracle’s health policy initiatives in the EMEA region, with emphasize on UK.
• Design and implement regulatory strategies to ensure compliance with software as a medical devices regulations in jurisdictions in the region, with emphasize on UK.
• 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 medical device laws, AI regulations, data privacy and health data regulations, fraud and abuse laws, and other relevant legal regulatory requirements in the region, with emphasize on UK.
• 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.
• Input into policy initiatives in the health and life sciences regulatory space in the EMEA region and globally.
• Collaborate cross-functionally with other teams, including internal product 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.

What you’ll bring

• We are seeking a regulatory attorney (Bachelor of Law or equivalent) with +8 years of legal experience in healthcare or life sciences. Minimum qualifications include an advanced degree with 6+ years of relevant work experience in healthcare or life sciences regulatory work.
• Knowledge of healthcare tech and life sciences regulatory requirements in Europe, and particularly the United Kingdom.
• 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.

Leadership competencies

• Performance, drive, and execution
• Collaboration
• Communicating for impact
• Inspirational leadership
• Competitive edge
• Change agility
• Mastering complexity

Career Level - IC4

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