Clinical Affairs Leader NEW

Summary:

The Clinical Affairs Leader will lead the development and execution of clinical protocols and clinical evaluation reports, ensuring compliance with regulatory and quality standards. Writes and implements protocols and plans necessary to support corporate objectives. This role bridges clinical operations with regulatory strategy, supporting the Company’s medical and regulatory objectives across pivotal and post-market studies.

Principal Tasks & Responsibilities:

• Write, review, and manage clinical protocols, study plans, and clinical reports.
• Ensure all clinical documentation adheres to GCP, ISO 13485, FDA, and MDR requirements.
• Collaborate with regulatory, quality, and R&D teams to support FDA submission and audits.
• Maintain clinical documentation and signatory records according to SOPs.
• Help lead clinical studies from First-in-Human (FIM) through IDE and post-market studies.
• Support clinical operations by monitoring study progress, timelines, and data quality.
• Contribute to the development of promotional materials, ensuring clinical content accuracy.

Qualifications:

Education:

• Bachelor’s degree in a relevant scientific discipline or equivalent; advanced degree preferred.

Experience:

• Minimum 6 years in Clinical Affairs with Class II and III medical device products, preferably with implantable, vascular or neurovascular devices.
• Proven experience in clinical protocol development, clinical reports and regulatory submissions.

Skills:

• Excellent communication, time management and multitasking skills in a fast-paced environment.
• Detail-oriented, results-driven with strong analytical and problem-solving skills.
• Strong understanding of clinical operations, study management, regulatory requirements (FDA,
• MDR) and quality system (ISO13485).