Sebastian Feye Email & Phone Number

San Diego, California

• Program Manager to plan and oversee design and development of medical devices to market. Activities include regulatory strategy, planning, pre-production, production and post-market. Acting Quality Manager to align all processes with 21 CFR 820 QSR’s and ISO 13485:2016• Developed Quality Management Systems for multiple firms in both hard copy and eQMS versions, implemented all major subsystems and ran Design Control and Risk Management implementation across multiple medical devices• Manage and assist clients to resolve various FDA Regulatory and Compliance issues, includes FDA 483 response and Warning Letter remediation projects to close-out• Manage Device and Drug FDA Registration and Listings, handling Import and Export Compliance and remediation of Product hold issues • Medical Device Regulatory Filings – 513(g), Pre-Submissions, 510(k)’s, Pre-EUAs, and EUA• 510(k) Submissions o K211209 – 2021 – Hycare International Nitrile and Latex Patient Examination Gloveso K200977 – 2020 – Operating Room Innovations Inc. Modular Toga Submission

San Francisco Bay Area

• Managed the budgeting, forecasting and spending prioritization across three domains (Security Engineering, Developer Experience, Business Tech Office) within the Core Platform Infrastructure organization. • Expense management with over 600 employees, across the portfolio around $300M of annual expenses.• Developed highly detailed plan at Director level assigning budgets and allocating spending from what was prior at a VP level only. Built presentations utilizing thinkcell software to break down all spending drivers and variances into understandable walks as well as constantly thinking of better forms of dissecting and cutting the data to provide variance analysis.• Developed three-year models of Maintenance contract portfolio as well seven-year models of PayPal’s main Data Centers across the US, accounting for contractual and planned kW usage and rent space, as well as additional costs. • Used multiple tools and systems to forecast and close on a monthly basis through SAP BPC, working with co-workers to develop dashboards to track discretionary employee spending, as well as building models and reporting utilizing and integrating disparate systems – ECC, Fieldglass, Workday, SRM.

Mountain View, Ca

Manage weekly bookings forecasts for all Online Acquisition Web Channels for Norton & now Lifelock as we have integrated. I am also responsible for expense management of the Sales and Marketing teams within the business unit. Other responsibilities include: Deal modelling, updating and refining ROI and CLV files, validating and improving SQL pulls for Finance and other ad-hoc projects. Constantly working on automating reporting processes and emphasizing easy understanding, scalability and simplicity to enable an easy hand over to other associates.

Mountain View, Ca

Managing the budgeting and forecasting of headcount and capital expenditures for four Enterprise Security Operating Organizations (over 900 employees).Tasked with the creation and processing of capitalization of Internally Developed Software (IDS) projects. Working on implementation of Oracle R12 process improvements to ensure understanding and compliance from developers and managers. Presented options to Accounting and Engineering to change the capitalization process in order to better reconcile Agile development with current waterfall accounting practices.

Mountain View, Ca

Developed Data analysis of risk trends over three year period, created presentation, which was shown at the Risk Assurance Global Team meeting in September in San Jose.Worked on operational audit of Global Expense Reporting by conducting research, interviews and identifying risks for the department. Researched Bitcoins and presented findings to department.

San Jose, Ca

Assisted in the creation of customized 401(k) proposals for institutional clients, supported team in meetings with clients & business associates.Performed Mutual Fund, 401(k), equity, bond & marketing research & analysis. Created and implemented marketing materials to attract new clients.

Santa Clara, Ca

Worked as a service professional working to meet many different needs of the University faculty, students and visitors.Also helped organize and set up events in the Kennedy Building with 100 to 150 attendees.

Greater San Diego Area

Performed extensive Mutual Fund data mining and analysis, discussing and testing financial models, researching potential portfolio options as well as portfolio analysis and attending Investment Meetings with clients.Streamlined business processes by creating Excel templates, research reports and organizing the digital and physical storage of the business.

Greater San Diego Area

Worked renting out Water Sports equipment. In addition acted as Assistant Manager and sailboat captain and instructor, managing up to 3 employees at a time and doing sailing trips for up to 6 customers at a time.

San Diego, Ca

Responsible for providing excellent Customer Service and ensuring guests comfort throughout their stay at the 315-guestroom hotel through personalized service.

San Diego, Ca

Started pet-sitting business for neighbors when they went on vacation.Through door to door marketing achieved steady business over the summers and created loyal client base.

Worked with Investment Broker, shadowing him and assisting in minor tasks for a week. Tasks included attending Investment Meetings with clients, learning techniques and inside tricks to portfolio management and organization.

Washington D.C. Metro Area

Worked for Congresswoman of the 43rd District of California, Susan DavisWorked with another Intern to read thousands of emails, organized them, categorized and responded to constituents in San Diego worked on refining process and communications organization.Helped certain staff members in their projects, collecting data and reading and summarizing thousands of letters and emails.

Master Of Science - Ms, Regulatory Affairs

Bachelor Of Commerce (B.Com.), International Finance

Bachelor Of Science In Commerce, Finance, 3.9

Activities and Societies: Sigma Chi Lambda Gamma Chapter, Entrepreneurship Club, Santa Clara Business & Law Club, Project Open Heart, Beta.