Analyst supporting regulatory execution and performance metrics at Mastercard. Focused on data insights for compliance and operational excellence in the technology function.
About the role
- Develop comprehensive project plans, including timelines, milestones, and deliverables, aligned with corporate objectives.
- Facilitate detailed planning sessions and ensure all project activities are tracked and managed to completion.
- Integrate design controls and risk management processes into project plans, ensuring compliance with regulatory standards.
- Lead and coordinate cross-functional project team meetings, document decisions, and assign clear ownership for action items.
- Define and communicate roles and responsibilities for all team members.
- Foster accountability and collaboration across internal and external stakeholders.
- Oversee the completion of design control documentation, including requirements flow-down, capabilities flow-up, and critical-to-quality (CTQ) specifications.
- Ensure product and system-level requirements are established, integrated, verified, and validated throughout the project lifecycle.
- Collaborate with Quality Assurance to maintain compliance for project documentation and design history files.
- Drive resource allocation and task management, resolving conflicts and prioritizing activities with department managers.
- Proactively identify project risks, develop mitigation strategies, and maintain unified cadence to meet milestones.
- Establish and publish project dashboards and key performance indicators (KPIs) to monitor progress and highlight risks.
- Implement new standards for requirements and specifications development, management, and traceability.
- Continuously improve project management processes to enhance efficiency and compliance.
Requirements
- Bachelor’s degree in engineering or equivalent training.
- Minimum 3 years’ experience in medical device product development (Class II or III devices; combination products preferred).
- Experience in the implementation and integration of FDA 21 CFR 820, including practical application in device development.
- Demonstrated expertise in design controls, risk management, and product realization.
- Familiarity with IND regulatory and commercialization pathway; knowledge of medical device regulatory requirements preferred.
Benefits
- Health Insurance: Fully company-paid premiums for employees’ medical, dental, and vision plans.
- Retirement Savings: Employer match up to 6% of annual salary to employees’ 401(k) plan when they save for retirement.
- Spending Accounts: FSA plans offered for both healthcare and dependent care; HSA available with high-deductible health plans.
- Income Protection: Fully paid basic life, AD&D, short-term disability, and long-term disability insurance for employees.
- Paid Time Off: Paid holidays and paid time off.
- Flexible Work Hours: Core hours 9:30 AM to 3:00 PM with flexibility to set your own schedule, depending on role.
- Parental Leave: Fully paid parent & child bonding leave for employees with one year of service.
- Workplace Perks: Complimentary beverages and snacks.
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