Beschreibung

In this role, you will oversee regulatory compliance and quality standards while shaping global strategies. Your day-to-day responsibilities will include managing submissions, guiding product design, and fostering a culture of quality excellence across teams.

Anforderungen

• •Minimum 8 years of experience with Bachelor's or Minimum 6 years of experience with a Master’s in business administration, Legal, Quality Management, Regulatory Affairs, Engineering, Science or equivalent disciplines
• •Demonstrated experience in the Medical Device/Biotech industry or equivalent in areas such as Medical Device, Quality Assurance, Quality Control, Quality Management, Quality Audit, Compliance Coordination or Warehouse Operations, Regulatory Strategy or compliance, International Regulations, Medical Device Regulations, Product Development
• •Minimum 5 years in a leadership position
• •Quality Management Procedures and Methodologies
• •CAPA Methodologies
• •Quality Assurance (QA)
• •Quality Management Systems (QMS)
• •Policy Development
• •Regulatory Compliance
• •Strategic Planning
• •Continuous Improvement
• •Budget Management
• •People Management
• •Business Acumen
• •Lean/Six Sigma Certification
• •ASQ Certified Quality Manager (CQM)
• •Regulatory Affairs Certification (RAC) for Medical Devices

Aufgaben

• •Oversee compliance with regulatory requirements and quality standards
• •Lead comprehensive monitoring systems and delegate responsibilities
• •Communicate and integrate updates into strategic plans
• •Shape and execute global regulatory and quality strategy
• •Align activities with Philips objectives and ensure regulatory compliance
• •Drive compliance with country-specific regulations for product registration
• •Manage submissions, documentation, and issue resolution
• •Influence product design and lifecycle decisions with regulatory strategy
• •Ensure quality and compliance throughout development and market execution
• •Provide oversight of quality management, safety, and compliance
• •Execute recalls, audits, and resolve compliance issues
• •Establish and maintain strategic relationships with regulatory agencies
• •Enforce harmonized regulatory and quality processes across functions
• •Conduct comprehensive management reviews and report on compliance activities
• •Verify product and device compliance with relevant regulations
• •Lead fulfillment of vigilance reporting and post-market requirements
• •Establish quality assurance practices, including audits and metrics monitoring
• •Manage compliance and quality issues, leading cross-functional discussions
• •Provide strategic guidance to leaders across domains
• •Identify opportunities for innovation and foster a culture of quality excellence
• •Execute business transformation initiatives aligned with corporate strategy
• •Lead organizational planning, staffing, budgeting, and methodological changes
• •Drive efficiency, effectiveness, and long-term sustainability
• •Lead succession planning and talent development for quality and regulatory teams
• •Contribute to refinement of organizational strategy and decision-making frameworks

Tools & Technologien