Regulatory Affairs Data Analyst

Medtronic • Memphis, TN

1d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Regulatory Affairs Data Analyst – Cranial & Spinal Technologies Onsite At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We're working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore, we are looking for a passionate Regulatory Affairs Data Analyst who has experience supporting regulatory operations through data analysis, reporting, and process improvement in a regulated medical device environment. Role Overview Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes with the goal of restoring long-term quality of life for more patients. CST is the market leader in spinal implants, robotics, and navigation. The Regulatory Affairs Data Analyst supports the CST Regulatory Affairs team by developing, maintaining, and analyzing regulatory data to drive informed decision making, improve submission timelines, and ensure compliance with global regulatory requirements. This role sits at the intersection of regulatory affairs and data analytics, providing critical insight that enables the team to operate efficiently and strategically.

Requirements

• Medical Device Regulatory Knowledge: Familiarity with FDA requirements, EU MDR, ISO 13485, ISO 14971, and global regulatory frameworks applicable to medical devices.
• Data Analytics Proficiency: Demonstrated ability to collect, organize, analyze, and visualize complex regulatory data to support decision making.
• Technical Skills: Proficiency in data analytics tools such as Power BI, Tableau, Excel, or similar platforms. Experience with regulatory information management systems and databases is a strong plus.
• Attention to Detail: Strong accuracy and organizational skills with the ability to manage multiple data streams and regulatory timelines simultaneously.
• Communication Skills: Strong written and oral communication skills with the ability to translate complex data into clear actionable insights for regulatory and cross functional stakeholders.
• Collaboration: Ability to work effectively across regulatory, quality, R&D, and operations teams in a matrixed organization.
• Independence and Initiative: Ability to work independently under general direction and proactively identify data gaps or process improvement opportunities.
• Must Have: Minimum Requirements 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.

Nice To Haves

• 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• 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.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees