Director of Clinical Evaluation and Excellence

Education and Experience:

· 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.

· Excellent communication, leadership, and project management skills.

Skills/Competencies:

· Excellent written and effective verbal communication skills.

· Ability to communicate cross-functionally across the organization.

· PC skills; word processing, spreadsheet, database, Internet search and utilization.

· Flexible and able to work in a fast paced environment.

· Team player.

· Ability to organize and judge priorities.

· Excellent ability to generate and maintain accurate records.

· Deep knowledge of FDA, EU MDR, ISO 13485, ISO 14155, ICH GCP, and country-specific regulations.

· Strong analytical, organizational, and communication skills.

· Proficiency in MS Office Suite and clinical documentation platforms.

· RAC certification preferred.