Overview
Senior Counsel, EMEA Health and Life Sciences — Join to apply for the Senior Counsel, EMEA Health and Life Sciences role at 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.
Responsibilities
* 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 emphasis on UK.
* Design and implement regulatory strategies to ensure compliance with software as a medical devices regulations in jurisdictions in the region, with emphasis 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 emphasis 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
Qualifications
Career Level - IC4
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.
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