Regulatory Affairs Specialist

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.

About the Role

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.

Pay

• Salary range for U.S. (excl. PR) locations: $74,400.00 – $111,600.00
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Benefits

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.

The following benefits and additional compensation are available to 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
• 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)
• 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.