Senior Manager, Medical Devices

Role Overview

• Lead and deliver regulatory and quality client projects across medical devices, IVD, and combination products
• Manage key client relationships and represent clients in interactions with Health Authorities and/or Notified Bodies
• Ensure projects are delivered to agreed KPIs, timelines, and budget
• Prepare, review, and compile high-quality regulatory and quality documentation to support medtech projects
• Provide day-to-day operational support and consultancy to clients on medtech intelligence, evolving requirements, and best practices
• Participate in regulatory, technical, and quality management processes for pharmaceutical, medical device, and diagnostic clients
• Communicate with clients and Health Authorities/Notified Bodies; support scientific advice procedures and represent clients in authority interactions as required
• Deliver seminars/lectures for colleagues, clients, and professional audiences; contribute to departmental expertise and knowledge-sharing
• Support company strategy implementation and continuous improvement; comply with and help optimise internal processes

Requirements

• University degree in Science, Medicine, Law, Engineering, or a related discipline
• Significant, hands-on experience in medical device and diagnostics (including IVD) regulatory affairs and quality management
• Strong analytical and critical-thinking skills, with a track record of resolving complex issues independently and pragmatically
• Proven project management capability (planning, execution, risk/issue management, and delivery to timelines and quality standards); experience driving change management initiatives is desirable
• Strong stakeholder management up to client department-head level; excellent written and verbal communication and presentation skills
• Business-fluent English and local language
• Companion Diagnostics (CDx) and/or combination products (desired)

Benefits

• A competitive compensation and benefits package aligned to experience and location
• A senior, highly visible role focused on meaningful client delivery in the medtech space
• The opportunity to work on a broad range of medical device, IVD, and combination product programmes with leading organisations
• A collaborative, expert-led environment where you can share knowledge, influence best practice, and drive continuous improvement
• Professional development opportunities to further deepen your regulatory/quality expertise and leadership capabilities