Senior Medical Device Clinical Operations Leader

AMARIS GROUP SA; Eindhoven; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

Amaris Consulting in the Netherlands seeks a Senior Clinical Operations Consultant to lead and mentor teams across medical device projects, delivering strategic oversight, operational leadership, and regulatory guidance. You will ensure studies meet ICH-GCP, ISO 14155, FDA requirements, MDR/IVDR, and internal quality standards while fostering cross-functional collaboration and process optimization.

This role offers exposure to global projects, a collaborative consulting culture, and

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medical Technology, or a related scientific discipline.
• Minimum 5–10 years of Clinical Operations experience in regulated healthcare industries.
• Experience leading clinical operations teams and managing multiple studies or projects.

Responsibilities

• Lead the planning, execution, and oversight of clinical studies across the study lifecycle.
• Provide strategic direction for clinical operations activities supporting product development and regulatory submissions.
• Ensure adherence to ICH-GCP, ISO 14155, FDA requirements, MDR/IVDR, and internal quality processes.
• Identify operational risks and implement mitigation strategies to maintain quality, timelines, and budgets.
• Lead, coach, mentor, and develop Clinical Operations professionals across project teams.
• Monitor KPIs, budgets, and performance; escalate risks when appropriate.
• Drive continuous improvement and standardization of clinical operations processes.

Skills

Strategic Leadership

Clinical Operations Management

Medical Device Clinical Research

Regulatory Compliance

People Management & Coaching

Budget Management

Stakeholder Management

Process Optimization

Decision Making

Analytical Thinking

Multi-project Management

Education

Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medical Technology, or related field

Tools

CTMS

EDC platforms

Document Management Systems

Audit Processes

Vendor Oversight

Job description

Amaris Consulting in the Netherlands seeks a Senior Clinical Operations Consultant to lead and mentor teams across medical device projects, delivering strategic oversight, operational leadership, and regulatory guidance. You will ensure studies meet ICH-GCP, ISO 14155, FDA requirements, MDR/IVDR, and internal quality standards while fostering cross-functional collaboration and process optimization.

This role offers exposure to global projects, a collaborative consulting culture, and