Senior Project Manager (Medical Devices & AI) JB-5297

A company is seeking a Senior Project Manager – Regulatory Affairs & Quality (Medical Devices & AI).

The role includes:

• Managing complex, multidisciplinary projects in the fields of medical devices and medical software.
• Leading regulatory affairs, quality assurance, certification, and international product registration processes.
• Supporting clients throughout the entire project lifecycle, from the planning stage through obtaining regulatory approvals.
• Managing interfaces with clients, regulatory authorities, professional teams, and international stakeholders.
• Responsibility for achieving professional, operational, and financial objectives.
• Creating value for clients and leading process improvement and optimization initiatives.

Requirements:

• At least 10 years of relevant experience – mandatory.
• Experience in at least one role as a Quality and/or Regulatory Affairs Manager in an innovative medical device manufacturing company – mandatory.
• Proven experience managing complex, multidisciplinary projects – mandatory.
• Passion for the fields of medical devices, regulatory affairs, and innovation – mandatory.
• Strong customer service orientation, excellent communication skills, and the ability to work with multiple stakeholders.
• Engineering degree – an advantage.
• ISO 13485 Lead Auditor certification – an advantage.
• Valid driver's license – mandatory.