Head of Regulatory Affairs and Quality Assurance

TN Italy; Italia; Remoto; EUR 60.000 - 100.000; Tempo pieno

Descrizione del lavoro

An innovative clinical-stage R&D company is seeking a Head of Regulatory Affairs and Quality Assurance to lead strategic initiatives in regulatory compliance and quality management. This executive role involves overseeing QA operations, managing submissions for regulatory approvals, and ensuring adherence to ISO 13485 standards. The position is primarily remote, with occasional travel to Milan required. Join a forward-thinking organization dedicated to developing groundbreaking treatments for solid tumors and make a significant impact in the medical field.

Competenze

• Extensive experience in Regulatory Affairs and Quality Assurance for medical devices.
• In-depth knowledge of ISO 13485 standards is essential.

Mansioni

• Develop and execute regulatory strategies for product approvals.
• Coordinate the implementation of the company's quality management system.

Conoscenze

Regulatory Affairs

Quality Assurance

Strategic Thinking

Leadership Skills

Knowledge of ISO 13485

Formazione

Degree in Medical or Scientific Discipline

Descrizione del lavoro

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Head of Regulatory Affairs and Quality Assurance, Italy

Client: Guided Solutions

Location: Italy

Job Category: Other

EU work permit required: Yes

Job Reference: 3124d64daef0

Job Views: 1

Posted: 06.05.2025

Expiry Date: 20.06.2025

Job Description:

Our client is a clinical-stage R&D company developing innovative treatments for solid tumour oncology. We are seeking an experienced Regulatory Affairs and Quality Assurance (QA) professional to join this executive role. The role manages the QA Director and reports directly to the CEO.

Note: The role is remote, but the company is based in Milan, Italy, and travel will be required.

Key Responsibilities:

1. Develop and execute regulatory strategies and manage submissions for regulatory clearance and approval.
2. Coordinate the implementation and maintenance of the company's quality management system (QMS).
3. Support project teams through product development and lifecycle, providing regulatory guidance.
4. Prepare and review technical documentation.
5. Represent the company in regulatory, quality, scientific, and investor meetings.

Candidate Requirements:

• A degree in a medical or scientific discipline (biology preferred).
• Extensive experience in Regulatory Affairs and Quality Assurance of class III implantable and/or combination medical devices.
• Experience leading RA/QA activities during pre-clinical and clinical stages for CE and FDA approval.
• In-depth knowledge of ISO 13485 standards.
• Managerial experience is preferred.
• Strategic thinking and leadership skills.