Senior Regulatory Program Manager
**Location: **Telecommuting/remote from within the US (eastern/central time zone ideal)
At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large global health companies require experienced regulatory leaders who can navigate complex and fast-changing regulations, and public policies across the globe. In this context, we are looking for a program manager in the medical device software and healthcare regulatory space, who will be leading actions that concern this broad array of opportunities globally. With his/her organizational 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 Program Manager on the Health and Life Sciences Legal and Compliance Team, you will work in collaboration with Product teams and subject matter experts to compile, track, and organize the required documentation to register products in global markets where the products are sold. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a program manager who is collaborative and creatively resolves problems to drive operational excellence across the Medical Device Regulatory Affairs department. Special consideration will be given to applicants with experience with Regulatory and/or Quality processes.
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
- Collaborate cross-functionally with teams to organize and support pre-market submissions and current registrations.
- Communicate progress and decisions needed through executive readouts and presentations. Strong PowerPoint skills preferred.
- Build and maintain integrated program plans across multiple teams/workstreams.
- Provide support for high-impact, business-critical projects to ensure successful execution
- Manage cross-functional initiatives and miscellaneous special projects on behalf of RA leadership
- Build and maintain reporting for key departmental priorities, risks, milestones, and dependencies.
- Standardize and improve Medical Device Regulatory Affairs processes, repositories, and documentation practices.
- Coordinate intake, prioritization, and status tracking for departmental requests and initiatives
- Manage preparation and submission of regulatory filings through electronic submission systems and regulator portals in every jurisdiction we do business in and for every product in the Oracle Health portfolio.
- Maintain expertise in the filing requirements, formats, workflows, and technical validation rules for relevant regulators.
- Coordinate submission timelines across cross-functional teams and ensure all required materials are received, reviewed, formatted, and filed on schedule.
- Perform quality checks on submission packages, including completeness, naming conventions, metadata, document formatting, version control, and portal validation.
- Track submission status, regulator acknowledgments, deficiencies, responses, approvals, and related correspondence.
- Maintain regulatory calendars, filing logs, evidence of submission, and audit-ready documentation.
Preferred Qualifications:
- BA/BS or advanced degree preferred, with at least 5 years of relevant experience (9+ with no degree).
- Experience in working within a quality management system, preferably with ISO 9001, ISO 13485, or Quality System Regulations.
- Understands continual improvement. Excellent organizational, written and verbal communication skills.
- Ability to adjust and adapt to rapidly changing priorities in a dynamic environment.
- Expertise with PowerPoint, Excel, SharePoint, Oracle Analytics Cloud and AI via Codex.
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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: $79,100 to $166,100 per annum. May be eligible for bonus and equity.
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 - IC3