Strategic CMF Medical Portfolio Lead

Mondeadditif; Heverlee; Sur place; EUR 80 000 - 130 000; Plein temps

Résumé du poste

Materialise Medical is seeking an experienced leader in CMF standard devices (implants and surgical instruments) to accelerate product development and streamline operations across R&D, manufacturing, quality, and regulatory. You will drive strategic direction and implement roadmaps to reduce time-to-market while ensuring regulatory compliance.

The role requires a proven track record in scaling processes across Europe and other regions, with strong problem-solving, collaboration, and stakeholder

Qualifications

• Minimum 10 years in CMF standard devices or regulated medical devices.
• Strong problem-solving and advanced knowledge in product R&D, manufacturing, quality, regulatory, and supply chain processes.
• Expertise in product development and/or logistics operations (loan, consignment, distributor sales, sterile product handling).
• Proven track record in reducing time from concept to launch within medical devices.
• Understanding of ISO 13485, EU MDR, FDA, and other global regulations and standards.

Responsabilités

• Define strategic direction and implementation roadmap.
• Lead a cross-functional change program for the CMF standard portfolio with the whole CMF business line, driving speed-to-market improvements.
• Collaborate with R&D, manufacturing, regulatory, and quality teams to implement optimized processes.
• Advise on the design and implementation of efficient and scalable logistics in multiple markets.
• Engage stakeholders and report progress, KPIs, and impact.

Connaissances

CMF devices experience

Regulatory knowledge

Cross-functional leadership

Description du poste

Materialise Medical is seeking an experienced leader in CMF standard devices (implants and surgical instruments) to accelerate product development and streamline operations across R&D, manufacturing, quality, and regulatory. You will drive strategic direction and implement roadmaps to reduce time-to-market while ensuring regulatory compliance.

The role requires a proven track record in scaling processes across Europe and other regions, with strong problem-solving, collaboration, and stakeholder