You'd lead a team of eight experienced clinical evaluation specialists running hundreds of projects at once. Their work underpins market access for almost every product this company sells outside the US. The Company This is a general eye health company with a broad portfolio covering surgical devices, contact lenses, and prescription and consumer eye care, sold in markets worldwide. It also includes some of the most experienced clinical evaluation professionals in the company. The company works across an international network of offices in Europe and has taken a forward-thinking position on AI. A dedicated in-house engineering team is already building bespoke tools, and clinical evaluation has been named a priority area for delivery in 2027. You'll help shape that work alongside the engineers building the tools, rather than waiting for an off-the-shelf licence from a vendor. Across four business units, a team of eight produces the clinical evaluation documentation that keeps the company's products on the global market. Without that work, market access for the portfolio outside the US doesn't hold. On top of the day-to-day portfolio, there are usually three or four high-priority projects a year: new product introductions, acquisitions and critical business decisions that need fast, accurate clinical evaluation input. Senior leadership watches these projects closely, and you'll be front and centre on them. The role is fully remote, with a small amount of travel for the annual team gathering and the occasional conference. On AI: the company is already using its in-house engineers to build agent-based tools for literature searches and CER development. Set clear objectives, manage performance and support each person's growth through coaching and regular development conversations.



Build and maintain one delivery plan covering the Vision Care, Surgical and Pharma/Consumer portfolios, line timelines up with regulatory milestones, and re-plan early when priorities change. Provide senior scientific oversight and review of Clinical Evaluation Plans and Reports, ensuring alignment with EU MDR 2017/745 requirements, relevant MDCG guidance, and the quality standards expected by notified bodies. Act as lead author or senior scientific reviewer on complex, high-priority or novel evaluations, including new product introductions and significant product changes where you need to be closely involved yourself. Collaborate with Regulatory Affairs, Medical Affairs, Quality and post-market surveillance colleagues to integrate clinical, safety and performance data into evaluation documentation and PMCF outputs. Play an active part in the company's AI programme, working with the internal engineering team to build and adopt bespoke tools that make the clinical evaluation function more efficient. Manage relationships with external medical writing and literature review partners, overseeing quality of outputs and ensuring outsourced work meets the same scientific standards as internal deliverables. Advanced degree (MSc, PhD or equivalent) in a life science or clinical discipline. A PhD is preferred, but strong experience at the right level will be considered instead. Medical device industry background, with surgical device experience required; ophthalmology experience is advantageous, though other surgical or complex device categories will be considered. Demonstrated people management experience, with direct line management of at least a small team over a sustained period, alongside an open and collaborative approach to leading experienced professionals. #

📌 Senior Manager, Clinical Evaluation (Madrid)
🏢 elemed
📍 Madrid