- Quality lead for assigned trials.
- Qualification of devices & vendors, ensuring certifications and documentation consistency.
- Oversight of DICE process for device assessment.
- Quality review of protocols, manuals, and clinical trial documents.
- Support of device evaluations, including IMPPAD activities.
- Mentor teams on digital health and computerized system quality.
- Guidance on classification of SaMD, wellness tools, CDS, etc.
- Oversight for patient-facing commercial digital solutions.
- Point of contact for Digital Health Technology SOPs and AI‐enabled quality procedures.
- Qualification of device, DHT, and computerized‐system vendors.
- Definition of acceptance criteria and lifecycle monitoring.
- Contribution to quality agreements.
- Independent planning and oversight of activities ensuring patient safety & compliance.
- Support for audits, inspections, deviations, trend reviews.
- Leadership in interdepartmental meetings.
- Contribution to QMS and process improvements.
- Coaching & mentoring junior staff.
- Master's degree in Life Sciences, Biomedical Engineering, Computer Science, Regulatory, etc.
- 5+ years in medical devices or pharma.
- Digital health, systems, or software experience advantageous.
- Experience with ISO 14971, FMEA, device qualification, combination products preferred.
- Understanding of global device regulations (EU MDR, FDA QSR, SaMD frameworks, IEC 62304, cybersecurity standards, GAMP5).
- English required.
- French or Dutch beneficial.
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Clinical and Digital Devices Quality Lead - Brussels - BioTalent
Beschrijving
The role ensures that all medical devices, digital health technologies (DHT), and computerized systems used in clinical trials — and where applicable beyond — meet quality and compliance requirements. This includes qualification, vendor oversight, and providing quality leadership across clinical and digital initiatives.
Key Responsibilities
Clinical
Digital
Vendor Qualification
Cross-functional
Education & Experience
Languages
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Quality Operations Lead
Alleen voor geregistreerde leden Belgium
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Data & Quality Technical Leader
Alleen voor geregistreerde leden Brussels
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Data & Quality Technical Leader
Voltijd Alleen voor geregistreerde leden Saint-Josse-ten-Noode - Sint-Joost-ten-Node
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Digital Quality Lead
Alleen voor geregistreerde leden Braine-l'Alleud
-
Solution Quality Lead
Alleen voor geregistreerde leden Belgium
-
Digital Quality Lead
Alleen voor geregistreerde leden Braine-l'Alleud, Walloon Region
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Quality Intelligence Network Lead
Alleen voor geregistreerde leden Belgium
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Quality Lead Bio MSAT
Alleen voor geregistreerde leden Belgium
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Devices Development Quality Lead
Alleen voor geregistreerde leden Belgium
-
Product Assurance Quality Lead
Alleen voor geregistreerde leden Charleroi
-
Product Assurance Quality Lead
Alleen voor geregistreerde leden Charleroi, Walloon Region
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Global Quality Lead Auditing Technology
Alleen voor geregistreerde leden Belgium
-
Clinical and Digital Devices Quality Lead
Alleen voor geregistreerde leden Brussels
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Clinical and Digital Devices Quality Lead
Alleen voor geregistreerde leden Brussels Region
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Senior Quality Lead – Clinical Activities
Alleen voor geregistreerde leden Jette
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Lead Product Quality
Alleen voor geregistreerde leden Denderleeuw
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Lead Product Quality
Alleen voor geregistreerde leden Denderleeuw, Flemish Region
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Quality Control Lead
Alleen voor geregistreerde leden Ninove
-
Quality Lead
Alleen voor geregistreerde leden Ghent
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Quality Lead
Freelance Alleen voor geregistreerde leden Ghent
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Vendor Quality Lead
Alleen voor geregistreerde leden Braine-l'Alleud