Senior Manager, Medical Devices
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Job Description
Senior Manager leading regulatory and quality client projects across medical devices at Cencora. Managing client relationships, ensuring project delivery, and compliance with regulations.
Responsibilities:
- 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
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