Senior Manager, Clinical Evaluation

elemed; España; Remote; EUR 120,000 - 160,000; Full time

Job summary

elemed, a global eye health company, seeks a senior leader to guide eight clinical evaluation specialists across four business units. The role ensures EU MDR-compliant CEP delivery and strong input to market access outside the US.

You'll shape the AI-enabled tools built in-house, collaborate with Regulatory, Medical Affairs and Quality, and drive strategic direction while developing the team and maintaining high scientific standards.

Qualifications

• Advanced degree in life science or clinical discipline; PhD preferred.
• Extensive experience authoring and reviewing CEPs/Clinical Evaluation Reports under EU MDR 2017/745.
• Medical device background with surgical device experience; ophthalmology advantageous.
• Proven people management with direct line leadership of a team.

Responsibilities

• Lead and develop a team of eight clinical evaluation professionals across four business units.
• Oversee delivery plans aligned with regulatory milestones and adapt to shifting priorities.
• Provide senior scientific oversight of CEPs and CERs, ensuring EU MDR and MDCG guidance compliance.
• Serve as lead author or senior reviewer on complex, high-priority evaluations including new product introductions.
• Define systematic literature review standards and ensure reproducibility and audit readiness.
• Collaborate with Regulatory Affairs, Medical Affairs, Quality and PMCF teams to integrate data into evaluations.
• Develop and revise SOPs and work instructions, maintaining document control standards.
• Contribute to the company AI programme by working with engineers to build bespoke tools.
• Manage relationships with external medical writing and literature review partners; ensure quality parity with internal outputs.
• Monitor EU MDR changes and translate impacts across the function.

Skills

Leadership

Project management

CEP writing

EU MDR oversight

Education

MSc/PhD in life science or clinical discipline

Job description

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. If you want a leadership role where the output carries that much weight, read on.

The Company

This is a global eye health company with a broad portfolio covering surgical devices, contact lenses, and prescription and consumer eye care, sold in markets worldwide. It's a large business, but the people who work there say it doesn't feel like a faceless corporation from the inside.

People inside the business consistently describe the culture as people-first. The team you'd be joining works independently and is well respected across the business. 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.

The Opportunity

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. You'd be the person responsible for making sure it does.

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.

It's a strong team. Several members have been with the company for two decades and are true experts in their areas. Your job is to lead them, not to do their work for them. They know what they're doing. What they need is a leader who trusts them and steps in with direction when it matters.

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. You don't need to write code. You do need an open mind and a willingness to work closely with the people building these tools. The way clinical evaluation is done here is about to change, and you'll help decide what it changes into.

What You'll Be Doing

• Lead and develop a team of eight clinical evaluation professionals across four business units. 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.
• Set the team's approach to systematic literature review, from search strategy through critical appraisal to evidence synthesis, so every output can be reproduced and stands up to inspection.
• 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.
• Set consistent standards for writing, review and document control across the team, and lead the development and revision of the relevant SOPs and work instructions.
• 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.
• Keep track of changes to EU MDR requirements and related guidance, assess what they mean for the team's processes, and share that knowledge across the function.

What We're Looking For

• 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.
• Substantial experience authoring and reviewing Clinical Evaluation Reports and CEPs under EU MDR 2017/745, with a proven track record of successful notified body review.
• 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.