CMF Standards Portfolio Lead - Medical Devices

Materialise; Vlaams-Brabant; On-site; EUR 110,000 - 170,000; Full time

Job summary

Materialise is seeking a seasoned Technical Portfolio Manager for CMF Standard to accelerate product development, streamline workflows, and reduce time-to-market across R&D, manufacturing, quality, and regulatory teams worldwide.

The ideal candidate has 10+ years in CMF standard devices or regulated medical devices, with deep knowledge of ISO 13485, EU MDR, and FDA requirements; they will drive collaboration and continuous improvement across multiple disciplines to deliver robust production

Qualifications

• 10+ years in CMF standard devices or regulated medical devices, with senior-level experience.
• Strong knowledge of ISO 13485, EU MDR, FDA and related global standards.
• Proven ability to lead cross-functional teams and drive strategic initiatives.

Responsibilities

• Define strategic direction and implementation roadmap for CMF standard portfolio.
• Oversee product and process development from concept to launch, reducing time-to-market.
• Collaborate with R&D, manufacturing, regulatory, and quality teams to optimize processes.
• Drive change leadership across departments to accelerate speed-to-market.
• Advise on scalable logistics and customer loan/consignment setups across markets.
• Engage stakeholders and report progress, KPIs, and impact.

Skills

CMF standard devices expertise

Regulatory knowledge

Cross-functional leadership

Process improvement

Supply chain processes

Time-to-market acceleration

Strategic mindset

Job description

Materialise is seeking a seasoned Technical Portfolio Manager for CMF Standard to accelerate product development, streamline workflows, and reduce time-to-market across R&D, manufacturing, quality, and regulatory teams worldwide.

The ideal candidate has 10+ years in CMF standard devices or regulated medical devices, with deep knowledge of ISO 13485, EU MDR, and FDA requirements; they will drive collaboration and continuous improvement across multiple disciplines to deliver robust production