About the Role:
At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires legal leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require a legal leaders 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 regulatory space, who will be leading decisions and actions that concern this broad array of risks and opportunities in the region. With his/her regulatory expertise and business acumen, he/she will play a pivotal role in driving Oracle's success and competitiveness in the healthcare and life sciences sector.
As Senior Counsel on the Health and Life Sciences Legal and Compliance Team, you will focus on medical device regulatory issues, as well as the legal issues that intersect with regulatory law, such as government investigations and litigation risk. The evolving law governing Artificial Intelligence will also be a deep focus of the role, particularly how it intersects with software as a medical device regulation. You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an attorney who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. Our attorneys are dedicated to excellence in their work, have instinctively good judgment and impeccable integrity. For this role we are seeking an attorney who is strategic, collaborative, and a creative problem-solver.
About the Business:
Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. It offers a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. 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.
What You’ll Do:
- Lead counsel on medical device legal regulatory issues impacting our customers’ use of Oracle products in the US, Canada, and Latin America, with a focus on software as a medical device, artificial intelligence and machine learning, real world data, and precision medicine.
- Advise on the appropriate regulatory standards for product qualification and classification analysis.
- Advise on the regulatory/compliance implications of and market standard terms for commercial transactions.
- Collaborate cross-functionally with other teams to help progress the regulatory and compliance programs goals and initiatives.
- Participate in pivotal initiatives to help improve Oracle’s business and to enable the fast and efficient completion of commercial transactions in a manner that is viewed positively by our customers and partners.
- Advise on changing regulatory requirements in the US, Canada, and Latin America that impact our businesses, regulatory affairs function, and quality/compliance programs.
- Input into policy initiatives in the health and life sciences regulatory space in the US, Canada, Latin America and around the globe.
Preferred Qualifications:
- A JD with 10+ years of legal experience in the software as a medical device industry.
- Expertise and experience as regulatory counsel working at the intersection of technology, life sciences, and healthcare.
- Knowledge of the laws governing software as a medical device, AI/ML software, clinical research, real world data, and related topics. Experience advising on whether software clinical decision support products qualify as a medical device and/or qualify for enforcement discretion.
- Experience reviewing commercial transactions in the health and life sciences sectors, particular transactions involving cutting edge technology.
- Professional demeanor, confident and innovative with ability to effectively counsel senior executives and clients
- Excellent writing, communication, analysis, negotiation and partnership skills.
- Problem solver (not just an issue spotter) with creative and innovative approach along with 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.
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Disclaimer:
Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $126,200 to $264,100 per annum. May be eligible for bonus, equity, and compensation deferral.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
- Medical, dental, and vision insurance, including expert medical opinion
- Short term disability and long term disability
- Life insurance and AD&D
- Supplemental life insurance (Employee/Spouse/Child)
- Health care and dependent care Flexible Spending Accounts
- Pre-tax commuter and parking benefits
- 401(k) Savings and Investment Plan with company match
- Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
- 11 paid holidays
- Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
- Paid parental leave
- Adoption assistance
- Employee Stock Purchase Plan
- Financial planning and group legal
- Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC4