Senior Manager, Medical Devices

Role Overview

• Lead and deliver regulatory/quality client projects for medical devices and diagnostics (IVD), serving as the Subject Matter Expert (SME) for Companion Diagnostics (CDx) and combined/combined studies
• Manage senior client relationships, represent clients with Health Authorities, and ensure delivery to KPIs, timelines, and budget
• Act as SME for CDx and combined studies, providing strategic and tactical regulatory guidance across client programs
• Develop and maintain strong client relationships; act as senior point of contact for delivery matters
• Lead planning and execution of client projects to KPIs; define milestones, governance and escalation pathways
• Coordinate and lead project teams (internal colleagues and qualified external partners); allocate work based on strengths and capacity; mentor and motivate staff
• Participate in regulatory, technical and quality management processes for medical device and diagnostic clients, including IVD and in-house manufacturing contexts where applicable
• Prepare, review and compile high-quality documentation within the framework of MDS projects
• Communicate with clients and Health Authorities; support scientific advice procedures and represent clients in authority interactions
• Oversee delivery to budget and manage resolution of invoicing queries related to assigned projects
• Provide day-to-day operational support and consultancy to colleagues and clients regarding MDS Services; share MDS intelligence and best practices
• Present seminars/lectures for colleagues, clients and professional audiences; contribute to departmental expertise
• Support company strategy implementation and continuous improvement; comply with and help optimize internal processes
• Take on other reasonable tasks aligned to role and capability, as agreed with management.

Requirements

• University degree in Science or Engineering
• Extensive experience in medical device/diagnostics regulatory and quality; strong capability to solve complex problems and operate independently
• Demonstrable leadership in mentoring/managing teams, project reengineering and change management
• Strong stakeholder management up to client department-head level; excellent written/verbal communication and presentation skills
• Business-fluent English and local language
• Deep expertise in CDx and combined studies (required)

Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.