Lead and continuously develop OrphaCare's global Project Management function, governance framework, and project management processes.

Establish and maintain a robust project portfolio management system aligned with corporate strategy and business objectives.

Provide strategic project leadership and decision support as a member of the leadership team.

Define, monitor, and report project KPIs, risks, resource requirements, and portfolio performance.

Lead, mentor, and develop a high-performing global project management team.

Manage departmental budgets and ensure effective allocation of internal and external resources.

Oversee the execution of product development, manufacturing, market access, geographic expansion, and post-merger integration projects.

Ensure projects are delivered on time, within budget, and according to agreed scope, quality, and regulatory requirements.

Manage external development partners, suppliers, consultants, and service providers to ensure successful project delivery.

Facilitate cross-functional collaboration, governance, and resolution of project escalations.

Bachelor's or Master's degree in Engineering, Biomedical Engineering, Industrial Engineering, or a related technical discipline.

PMP, PRINCE2, IPMA, or equivalent project management certification

10+ years of progressive project management experience, including leadership of cross-functional teams within the medical device industry.

Proven track record of leading complex medical device development projects from concept through commercialization.

Experience working within outsourced development models and managing external development partners.

Experience operating in both European and US regulatory environments.

Strong understanding of medical device development processes, design controls, risk management, verification, and validation activities.

Solid knowledge of EU MDR, FDA medical device regulations, ISO 13485, ISO 14971, and product lifecycle management principles.

Experience with manufacturing transfer, supplier management, and commercialization activities.

Strong strategic leadership, stakeholder management, negotiation, and organizational change management skills.

Fluent English (C1/C2) with excellent communication and influencing abilities.