Regulation and Quality Project Manager JB-5297

We are seeking a Senior Project Manager - Regulation and Quality in the field of Medical Devices and AI.

The role includes:

• Managing complex and multidisciplinary projects in the field of medical devices and medical software.

• Leading regulatory processes, ensuring quality, documentation and international registration.

• Accompanying clients throughout the entire project lifecycle, from the planning phase through obtaining regulatory approvals.

• Managing interfaces with clients, regulatory bodies, professional teams and international entities.

• Responsibility for meeting professional, operational and financial targets.

• Creating client value and leading improvement and optimization processes.

Requirements:

• At least 10 years of experience in the field – mandatory.

• At least one position as a Quality and/or Regulation Manager in a manufacturing Innovative medical device company – mandatory.

• Experience in managing complex and multidisciplinary projects – mandatory.

• High service awareness, excellent communication skills and ability to work with multiple interfaces.

• Engineering degree – an advantage.

• ISO 13485 Auditor certification – an advantage.

• Valid driver's license – mandatory.