Medtronic is a leader in global healthcare technology, dedicated to alleviating pain and restoring health. The Regulatory Affairs Data Analyst will support the CST Regulatory Affairs team by developing and analyzing regulatory data to enhance decision-making and ensure compliance with global regulations.
Develop and maintain regulatory dashboards, metrics, and reports to track submission status, approval timelines, license maintenance activities, and regulatory commitments across global markets
Develops, automates, and maintains regulatory analytics, Custom GPTs, and AI agents to improve efficiency, data quality, traceability, and visibility into regulatory status, risks, and timelines
Analyze regulatory data to identify trends, risks, and opportunities for process improvement within the regulatory affairs function
Support the preparation and tracking of FDA, EU MDR, and international regulatory submissions by managing data inputs, timelines, and documentation requirements
Collaborate with Regulatory Affairs Specialists, Quality, R&D, and Operations teams to ensure accurate and complete regulatory data is captured and maintained across systems
Maintain and update regulatory databases and tracking tools including product registration records, submission logs, and license renewal schedules
Generate standard and ad hoc reports to support regulatory strategy discussions, leadership reviews, and cross functional planning
Support post market vigilance reporting and product recall activities through data collection, analysis, and documentation
Assist in identifying and implementing process improvements to enhance data quality, reporting efficiency, and regulatory compliance tracking
Partner with IT and data teams to support system enhancements and digital transformation initiatives within the regulatory affairs function
Ensure data integrity and accuracy across regulatory information systems in compliance with applicable regulatory requirements and internal quality standards
Qualification
Required
Bachelor's degree in a scientific discipline, data science, information systems, or equivalent with 2 years of relevant experience, or an advanced degree with 0 years of experience
Familiarity with FDA requirements, EU MDR, ISO 13485, ISO 14971, and global regulatory frameworks applicable to medical devices
Demonstrated ability to collect, organize, analyze, and visualize complex regulatory data to support decision making
Proficiency in data analytics tools such as Power BI, Tableau, Excel, or similar platforms
Strong accuracy and organizational skills with the ability to manage multiple data streams and regulatory timelines simultaneously
Strong written and oral communication skills with the ability to translate complex data into clear actionable insights for regulatory and cross functional stakeholders
Ability to work effectively across regulatory, quality, R&D, and operations teams in a matrixed organization
Ability to work independently under general direction and proactively identify data gaps or process improvement opportunities
Preferred
2 to 5 years of industry experience in regulatory affairs, quality, or a data analytics role within a regulated medical device or biotechnology environment
Advanced degree in engineering, biological sciences, health sciences, data science, or a related field
Experience with regulatory submission tracking systems such as Agile PLM, Veeva Vault, or similar platforms
Familiarity with FDA 510(k), PMA, or EU MDR submission processes
Experience supporting regulatory compliance reporting including post market vigilance and product registration maintenance
Knowledge of data governance principles and data integrity requirements in regulated environments
Proficiency in Microsoft Office Suite including Excel, PowerPoint, and Project
Experience with SQL, Python, or R for data analysis is a plus
Benefits
Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
