Note: The job is a remote job and is open to candidates in USA. Oracle is a global leader in providing software and solutions to the healthcare and life sciences sectors. They are seeking a Senior Counsel to lead legal regulatory issues related to medical devices, particularly in the software as a medical device space, ensuring compliance with evolving healthcare regulations and advising on commercial transactions.
Responsibilities
- 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
Skills
- 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, particularly 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
Benefits
- 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
Company Overview
Oracle is an integrated cloud application and platform services that sells a range of enterprise information technology solutions. It was founded in 1977, and is headquartered in Austin, Texas, USA, with a workforce of 10001+ employees. Its website is https://www.oracle.com/.