Remote Senior Manager, Clinical Evaluation & AI Tools

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

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.