05/21/2025 updated
60 % partially available
Regulatory Expert Medical Devices with 20+ years experience in US regulatory strategies
Maaseik, Belgium
Only remote
PhD Student, Catholic University of Leuven3D PrintingArtificial IntelligenceBiocompatibilityMedical ImagingComplianceRecords ManagementSterilizationImage ProcessingNotified BodyPackage TestingQuality ManagementRadiologyTestingAerospace IndustriesRegulatory Developments
US Regulatory Strategy
Development of regulatory strategies for medical devices, facilitating US market access through 510(k) premarket notifications with over 50 successful submissions.
Regulatory Affairs Management
Regulatory roadmap development for medical devices, guiding companies through complex regulatory systems in US, EU, Japan, Canada and Latin-America.
Quality Management Systems
Implementation and management of full quality management systems covering medical, automotive and aerospace activities, ensuring compliance with industry standards.
Patient-Specific Device Development
Experience with 3D-printed devices and implants, creating customized medical solutions.
Radiological Image Processing
Knowledge of software and AI applications for medical imaging analysis.
Technical File Management
Coordination of technical file reviews by Notified Body, ensuring regulatory compliance documentation.
Biocompatibility Testing
Oversight of biocompatibility, cleaning, sterilization and packaging testing for medical devices.
Development of regulatory strategies for medical devices, facilitating US market access through 510(k) premarket notifications with over 50 successful submissions.
Regulatory Affairs Management
Regulatory roadmap development for medical devices, guiding companies through complex regulatory systems in US, EU, Japan, Canada and Latin-America.
Quality Management Systems
Implementation and management of full quality management systems covering medical, automotive and aerospace activities, ensuring compliance with industry standards.
Patient-Specific Device Development
Experience with 3D-printed devices and implants, creating customized medical solutions.
Radiological Image Processing
Knowledge of software and AI applications for medical imaging analysis.
Technical File Management
Coordination of technical file reviews by Notified Body, ensuring regulatory compliance documentation.
Biocompatibility Testing
Oversight of biocompatibility, cleaning, sterilization and packaging testing for medical devices.
Experience
Professional experience10+ years
Freelancer since2020
Languages
EnglishFluentFrenchBasic knowledgeDutchNative speaker
Project history
As a self-employed consultant, guiding medical device companies (start-ups, scale-ups) through the complex US regulatory system: fast, efficient and based on a custom developed approach.
Responsible for defining regulatory strategies for 510(k) premarket notifications for novel devices within the Materialise product portfolio, in collaboration with product development. Support of regulatory submissions in US, EU, Japan, Canada as well as Latin-America. Coordination of face-to-face meetings with US FDA, coordination of Technical file reviews by Notified Body. Regulatory representation in the team responsible for biocompatibility, cleaning, sterilization and packaging testing. People manager of ~10 persons.
Responsible for the full quality management system of the company (covering medical as well as automotive and aerospace activities) as well as regulatory submissions. Member of the executive team of the company, people manager of ~10 persons.