Digital Transformation & AI Manager (Regulatory & Quality)
Core
A hands-on Regulatory Affairs and Quality Assurance (RAQA) professional driving the practical adoption of automation and digital solutions to reduce manual workload and improve data consistency in a regulated medical device environment.
Role type
Manager, Regulatory & Quality Automation
Builds
End-to-end automation solutions for RAQA processes, including document compilation, data validation, and repetitive task automation.
Domain
Medical Devices / Regulated Industries / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Regulatory Affairs process expertise, Quality Assurance process expertise, process improvement, automation solution design, validation of automation solutions, compliance with ISO 13485 and GxP, documentation for regulated environments, collaboration with IT and SAP teams, data handling, scripting (Python, Visual Basic), version control (GitHub), low-code solutions (Power Automate, Power Apps, UiPath)
Preferred skills
MDR / IVDR and FDA familiarity, SAP or SharePoint familiarity, AI-assisted development environments exposure
Technologies
Power Automate, Power Apps, UiPath, Python, Visual Basic, Excel, GitHub, SAP, SharePoint
Responsibilities
Analyze RAQA processes to identify automation opportunities, design and implement end-to-end automation solutions, ensure all automation solutions are validated and compliant, produce and maintain documentation suitable for regulated environments, promote automation mindset within RAQA, collaborate with IT and SAP teams on architecture and integrations
Seniority
Manager, hands-on IC
