Job Title: Clinical Devices & Digital Quality Lead
Location: Brussels, Belgium (Hybrid-2 days per week onsite)
Duration: ASAP-12 months with possible extension
Languages: English
Job Summary
This is a global role responsible for ensuring that all medical devices, digital health technologies, and computerized systems used in clinical trials (and, when applicable, outside clinical trials) meet applicable quality, compliance, and regulatory requirements.
The role embeds quality from device and digital technology selection through operational use by:
* Partnering with internal and external stakeholders
* Mentoring and advising cross-functional project teams
* Performing qualification of medical devices, digital health technologies, computerized systems, and vendors
* Supporting planning, prioritization, and escalation activities within the Clinical Development Devices Quality function
Major Accountabilities
Clinical Scope
* Serve as Quality Lead for assigned clinical trials, providing independent quality oversight.
* Perform and document qualification of medical devices and vendors used in clinical trials, including:
* Fit-for-purpose and context of use assessments
* Verification of certifications and regulatory status
* Review for consistency across technical and clinical documentation
* Review clinical study documentation (e.g., protocols, IMP handling manuals) from a quality perspective to ensure patient safety and data quality.
Digital Scope
* Act as Quality Mentor for projects involving computerized systems and digital health technologies.
* Advise project teams on compliance expectations, required documentation, and inspection readiness for digital systems used in clinical trials.
Vendor Qualification
* Qualify vendors of medical devices, digital health technologies, and computerized systems across clinical and non-clinical contexts.
* Define vendor acceptance criteria and required evidence packages.
* Engage with vendors and perform periodic lifecycle reviews.
* Address quality questions related to vendor qualification.
* Draft and support Quality Agreements between our vendors where required.
Cross-Functional Responsibilities
* Independently define, plan, coordinate, and execute activities to ensure:
* Patient safety
* Data quality
* Regulatory compliance
* Escalate risks and issues to management when appropriate.
* Support inspections and investigations conducted by international and national regulatory authorities.
* Review and trend data from audits, deviations, and risk analyses.
* Perform impact assessments of complaints, deficiencies, and malfunctions.
* Synthesize quality signals across programs and recommend improvements to senior management and other departments.
* Represent Device Quality in interdepartmental and project team meetings, taking a leadership role when required.
* Deliver presentations to peers, senior management, and industry audiences.
* Act as a role model for change and support continuous process improvement.
* Coach and mentor junior colleagues, fostering innovation and knowledge sharing.
Education & Experience
Education
* Master’s degree with a relevant academic background
* Background in digital health or software is highly desirable
Experience
* Minimum 5 years’ experience in a medical devices and/or pharmaceutical environment
* Understanding of selecting fit-for-purpose devices from First-in-Human (FIH) to Phase 4 clinical trials
* Hands-on experience with digital health technologies or computerized systems is an asset
Regulatory & Standards Knowledge
In-depth familiarity with:
* ISO 14155
* ISO 13485
* EU Medical Device Regulation (EU MDR)
* 21 CFR Part 820
* Relevant guidance, including:
* FDA Guidance on Digital Health Technologies for Remote Data Acquisition
* EMA Guidance on Computerised Systems in Clinical Studies
Competencies
* Strong knowledge of regulations, quality principles, and business processes for:
* Medical devices
* Digital health technologies
* Computerized systems
* Demonstrates leadership and influence across cross-functional and cross-cultural teams
* Coaches and mentors colleagues and shares technical expertise through training
* Excellent interpersonal, verbal, and written communication skills
* Confident presenter in internal and external forums
* Independently analyzes data, identifies risks, and proposes corrective and preventive actions
* Shows initiative and applies creative, practical problem-solving skill