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Director of Clinical Evaluation and Excellence
Director of Clinical Evaluation and ExcellenceGardner Resources Consulting, LLC • Lexington, MA, US
Director of Clinical Evaluation and Excellence

Director of Clinical Evaluation and Excellence

Gardner Resources Consulting, LLC • Lexington, MA, US
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  • [job_card.full_time]
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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.
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