E2E Regulatory Affairs (RA) & Quality Management (QM) Process Expert

Key Skills: QMS, Transformation, Oracle ERP, Regulatory regulations, Global Process Manager, Sap, SAP S4 HANA, QM

Roles and Responsibilities:

• Own the global design and continuous improvement of end-to-end Regulatory Affairs and Quality Management processes.
• Lead business process transformation initiatives involving Oracle ERP, SAP, and quality management systems.
• Establish governance for regulatory, quality, and controlled process documentation across global business units.
• Translate regulatory requirements into scalable business processes, system capabilities, controls, and operating procedures.
• Coordinate international stakeholders across Regulatory Affairs, Quality, IT, manufacturing, supply chain, and commercial functions.

Skills Required:

• 8 - 13 years of relevant experience in Regulatory Affairs, Quality Management, ERP transformation, or global process management within MedTech, pharmaceutical, or life sciences organizations.
• Hands-on experience with Oracle ERP, SAP, and QMS environments in MedTech, pharmaceutical, or life sciences organizations.
• Proven ownership of global process management and business transformation programs spanning Regulatory Affairs and Quality Management.
• Strong understanding of regulatory regulations, quality governance, controlled documentation, and compliance requirements.
• Experience defining process architecture, business requirements, system integration needs, implementation roadmaps, and user adoption plans.

Good to Have:

• Experience with QM processes and SAP S/4HANA.

Education: Bachelor's or master's degree in life sciences, pharmacy, engineering, quality management, regulatory affairs, business administration, or a related discipline.