Project Manager (SciPharm)

Teilzeit Turnhout

We are looking for a Project Manager (Part-time 24h/week) to lead selected medical device development projects and post-market activities. In this role, you will ensure projects are planned and executed on time, within budget, and in line with applicable regulatory and quality requirements in the European Union and the United States. You will combine strong project leadership with hands-on ownership of development deliverables in a predominantly outsourced development model.

What Your Day To Day Will Look Like

Lead medical device development and design-transfer projects, including Class II/III.
Manage manufacturing, supply chain, market access, reimbursement, and market-entry projects.
Define product requirements and ensure alignment across development, risk management, verification, validation, and clinical activities.
Develop and manage project plans, timelines, budgets, resources, risks, and key milestones.
Ensure projects are delivered on time, within budget, and in line with quality, regulatory, and business requirements.
Manage external development partners, suppliers, consultants, and service providers.
Monitor external partner performance, deliverables, timelines, budgets, and project risks.
Ensure development activities and documentation comply with EU MDR, FDA requirements, and applicable medical device standards.
Collaborate with Manufacturing, Quality, Regulatory, Clinical, Supply Chain, and Commercial teams.

Your Qualifications And Experience

Bachelor’s or Master’s degree in Engineering or a related technical field.
3+ years of project management experience, ideally in medical devices (Class II/III).
Experience managing external development partners, suppliers, and outsourced projects.
Good understanding of medical device development, design controls, risk management, verification, and validation.
Solid knowledge of EU MDR, FDA medical device regulations, ISO 13485, and ISO 14971.
Experience with manufacturing transfer, process qualification, or commercialization is a plus.
Project management certification such as PMP, PRINCE2, or IPMA is an advantage.
Strong stakeholder management, negotiation, and decision-making skills.
Fluent English (C1/C2), written and spoken.
Valid driving licence.

Our offer

Open corporate culture with the opportunity to bring in your own ideas
Great opportunities for personal and professional development
Attractive work environment with excellent career opportunities and flat hierarchies
Competitive salary package plus bonus and various benefits

APPLY NOW

Please submit your application exclusively via the application link.

Main Benefits

Bonus

Company car

Employee mobile phone

Laptop

Initial and continuing education

Canteen

Your Contact

Kenny Trappl

Talent Acquisition Manager

Needs. Science. Trust.

As a privately owned company, AOP Health is devoted to long-term commitment, high quality, and continuity. For a small number of very special diseases the company is sole supplier of some key therapeutic agents throughout the world.