Director of Clinical Evaluation

Job Summary

A company is looking for a Director of Clinical Evaluation and Excellence.

Key Responsibilities

• Lead clinical development strategies to align with corporate and regulatory goals
• Oversee design, execution, and reporting of clinical trials and ensure compliance with global regulatory standards
• Manage a team of regulatory specialists and ensure high-quality documentation for regulatory submissions

Required Qualifications

• Bachelor's degree in Life Sciences or related field (advanced degree preferred)
• Minimum 10 years of experience in clinical research, regulatory affairs, and quality assurance within the medical device industry
• Proven leadership in global regulatory strategy and clinical documentation
• Strong understanding of FDA, EU MDR, ISO 13485, ISO 14155, and ICH GCP regulations
• RAC certification preferred