Regulatory Affairs Specialist

About this role

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

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