Director of Clinical Evaluation and Excellence

The Director of Clinical Evaluation and Excellence will lead global clinical research activities to ensure regulatory compliance across pre-market and post-market studies. The role oversees global regulatory submissions, safety reporting, EU MDR documentation (CERs, CEPs, PMCF), clinical audits, and QMS support. The ideal candidate brings strong expertise in medical device regulations, clinical documentation, and cross-functional leadership.

Key Responsibilities:

• Lead clinical strategy and ensure alignment with regulatory requirements.
• Oversee design, execution, and reporting of feasibility, pivotal, and post-market trials.
• Ensure compliance with FDA, ISO 14155, EU MDR, and global regulations.
• Serve as clinical SME for regulatory interactions.
• Prepare and submit regulatory/IRB documentation; manage responses to inquiries.
• Lead gap assessments, process updates, and global safety reporting.
• Manage AE reporting, protocol deviations, complaints, and safety committees.
• Direct CERs, CEPs, PMCF plans/reports, and clinical study reports.
• Lead audits, CAPA activities, and inspection readiness.
• Mentor teams across regulatory, clinical writing, quality, and safety.
• Drive compliance, collaboration, and continuous improvement.

Qualifications:

• Bachelor’s in Life Sciences (advanced degree preferred).
• 10 years in clinical research, regulatory affairs, and quality in medical devices.
• Proven leadership in global regulatory strategy and clinical documentation.
• Excellent communication and project management skills.

Skills:

• Strong knowledge of FDA, EU MDR, ISO 13485, ISO 14155, ICH GCP.
• High proficiency in clinical documentation tools and MS Office.
• Strong analytical, organizational, and cross-functional communication skills.
• RAC certification preferred.