Regulatory Affairs Data Analyst
Medtronic
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.
A Day In The Life
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.
To Be Successful in This Role
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 Have
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.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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).
The following benefits and additional compensation are available to all regular employees: 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).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.