Global Clinical Evaluation Lead

Job Summary

To oversee the development and maintenance of clinical evaluation and post-market clinical documentation, the hybrid Global Clinical Evaluation Lead will manage Clinical Evaluation Plans, Reports, and associated literature activities while collaborating with internal and external stakeholders to ensure regulatory compliance and market access.

Key responsibilities

• Lead the preparation, review, and finalization of clinical evaluations and documentation in compliance with EU MDR requirements
• Manage relationships with external clinical evaluation partners, including training and governance meetings
• Act as a clinical subject matter expert, providing input during Product Core Team meetings and annual Post Market Surveillance meetings

Required qualifications

• Advanced scientific degree (e.g., PhD, MSc), MD, or BS/BA in sciences or nursing, or equivalent combination of education and experience
• Minimum 3 years of industry experience within Medical Devices or Pharmaceuticals
• Strong understanding of European Medical Device Directive (MDD) and EU MDR
• Proven experience analyzing and summarizing clinical data for stakeholders
• Experience conducting and reviewing literature searches and appraisals