Regulatory Affairs Specialist

Regulatory Affairs Specialist

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.

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

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.