Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 28 Aug 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

At Medtronic Neuroscience , we bring innovation, expertise, and purpose together to improve care for people living with neurological, spinal, and chronic pain conditions. Our technologies help restore function, improve quality of life, and support better outcomes for patients around the world.

Cranial & Spinal Technologies (CST) advances surgical care for patients with spine and cranial conditions. We develop innovative solutions that help clinicians plan, navigate, and deliver procedures with accuracy, efficiency, and patient outcomes in mind.

Check us out on LinkedIn: Medtronic CST

The Regulatory Affairs Specialist is responsible for leveraging data, analytics, and digital tools to support Regulatory Affairs strategies, compliance activities, operational excellence, and business decision-making. This role partners with Regulatory Affairs, Quality, R&D, IT, Supply Chain, and other cross-functional teams to collect, analyze, interpret, and visualize regulatory data to improve compliance, data quality, process efficiency, and regulatory intelligence.

The RAS transforms complex regulatory data into actionable insights, develops dashboards and metrics, identifies trends and risks, and supports regulatory systems, submissions, registrations, and data governance initiatives.

Primary Responsibilities

Data Analytics & Insights

• Collect, cleanse, validate, and analyze regulatory data from multiple systems and sources.

• Develop dashboards, reports, scorecards, and KPIs to support Regulatory Affairs operations and leadership decision-making.

• Identify trends, risks, bottlenecks, and opportunities for process improvement using data analytics techniques.

• Conduct root cause analysis and provide data-driven recommendations to improve regulatory compliance and operational effectiveness.

• Support forecasting, workload analysis, resource planning, and regulatory metrics reporting.

Regulatory Data Governance

• Support regulatory data governance initiatives and ensure data accuracy, consistency, and integrity across systems.

• Monitor and improve regulatory master data quality.

• Define, document, and maintain data standards, business rules, and data management processes.

• Partner with business stakeholders to resolve data discrepancies and implement corrective actions.

Systems & Digital Solutions

• Serve as a business partner for regulatory information management systems and related digital platforms.

• Support system enhancements, testing, validation activities, and user acceptance testing (UAT).

• Collaborate with IT and business teams to automate reporting and streamline regulatory processes.

• Develop Power BI dashboards, analytics solutions, and process automation opportunities.

Regulatory Operations Support

• Support regulatory submission, registration, licensing, and product maintenance activities through data analysis and reporting.

• Monitor regulatory commitments, filings, renewals, and compliance-related metrics.

• Assist in regulatory audits, inspections, and compliance assessments through data gathering and reporting.

Continuous Improvement

• Apply Lean, Six Sigma, and process improvement methodologies to improve regulatory workflows.

• Identify automation opportunities and drive efficiency initiatives.

• Develop metrics to measure process effectiveness and business outcomes.

Cross-Functional Collaboration

• Partner with Regulatory Affairs SMEs, Data Stewards, Product Teams, Quality, IT, Supply Chain, and Program Management teams.

• Present findings and recommendations to stakeholders and leadership.

• Support training and adoption of analytics tools and data-driven decision-making practices.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Information Systems, or related field.

• Minimum 2 years of experience in Regulatory Affairs, Regulatory Operations, Data Analytics, Data Management, or related function.

• Experience analyzing large datasets and translating findings into business insights.

• Strong analytical and problem-solving skills.

• Advanced Microsoft Excel skills.

• Experience with Power BI, Tableau, SQL, Power Query, or similar analytics tools.

• Experience working with regulatory systems and databases.

• Strong written and verbal communication skills.

Preferred Qualifications

• Experience in the medical device, pharmaceutical, biotechnology, or regulated healthcare industry.

• Knowledge of FDA, EU MDR, IVDR, Health Canada, and other global regulatory requirements.

• Experience with RIM systems (Calyx, Veeva Vault RIM, Windchill, SAP, etc.).

• Lean Six Sigma Green Belt or equivalent process improvement experience.

• Experience with data migration, master data governance, and digital transformation programs.

• Familiarity with AI, machine learning, predictive analytics, or automation technologies.

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.

‌

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on aiapply.co .

‌

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.

Salary ranges for U.S (excl. PR) locations (USD):$74,400.00 - $111,600.00This 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

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.