Senior Lecturer Quality Management for Biomedical Sciences Master Students at UHasselt

QA Manager - Head of Quality and Regulatory AffairsResponsibilities- Accountable for the ISO13485 QMS, including approval of all SDLC documentation, complaint handling and non-conformity management.- Accountable for global regulatory compliance and strategy- Accountable for the global registration of UgenTec's medical device products (FDA(510(k), IVDR, ...)Achievements- Guide UgenTec's transition from a start-up to a scale-up company from a QA and RA… Show more QA Manager - Head of Quality and Regulatory AffairsResponsibilities- Accountable for the ISO13485 QMS, including approval of all SDLC documentation, complaint handling and non-conformity management.- Accountable for global regulatory compliance and strategy- Accountable for the global registration of UgenTec's medical device products (FDA(510(k), IVDR, ...)Achievements- Guide UgenTec's transition from a start-up to a scale-up company from a QA and RA perspective- 2020 - Lead UgenTec's participation in COVID_19 testing from a QA and RA perspective- 2020 - Expert panel member at COCIR's panel discussion on medical device software and Artificial Intelligence- 2019 - Develop and implement IVDR strategy for UgenTec's medical device products- 2019 - Successfull registration of UgenTec's medical device products in EU, US, AUS, CAN- 2018 - Obtain ISO13485:2016 certificate Show less

- Set strategies around reporting and metrics aligned with business needs. - Introduce innovations in the quality metrics and analytics area in order to provide real-time, proactive and valid conclusions to the business.- Analyze quality and compliance data in order to support a data driven, risk based audit strategy. - Develop, generate and present reliable quality metrics and assist in the translation to executable action plans.- Lead/contribute to cross-departmental process… Show more - Set strategies around reporting and metrics aligned with business needs. - Introduce innovations in the quality metrics and analytics area in order to provide real-time, proactive and valid conclusions to the business.- Analyze quality and compliance data in order to support a data driven, risk based audit strategy. - Develop, generate and present reliable quality metrics and assist in the translation to executable action plans.- Lead/contribute to cross-departmental process improvement and strategic projects.- Train/mentor new employees, quality and compliance consultation.- Assist in regulatory health authority inspections.- Plan, conduct and report study-specific, system or facility audits of internal and external (pre)clinical activities. Show less

R&D QA Audits - GLP, GCLP, GCP, CSV - Study specific audits, Process audits, Facility audits, System audits, Vendor audits