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

Director of Clinical Evaluation and Excellence

Gardner Resources Consulting, LLC • Lexington, MA, US

4 days ago

Job type

Full-time

Job description

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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Director Of Clinical • Lexington, MA, US

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