IVD Regulatory Lead & Team Leader

TRIUM Clinical Consulting NV; Antwerpen; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Restaurant d'entreprise

Indemnités de stage/alternance

Résumé du poste

QbD Group in Belgium is seeking a Senior Consultant to lead Legal Representative Services for IVD clients, combining regulatory strategy with team leadership.

You will own submissions, coordinate multi-country activities, mentor the team, and build strong client relationships while representing the company at industry events.

A Master’s degree and 8+ years of regulatory affairs experience are required; fluent English is essential.

Qualifications

• Master's degree in Sciences, Biomedical Sciences, Medicine, Engineering, or Technology.
• Minimum 8 years of Regulatory Affairs experience for IVD/Medical Devices.
• Experience with IVD legal representative responsibilities and submissions is a strong plus.
• Demonstrated experience in managing complex projects and advising clients.
• Experience coordinating the work of others, mentoring, coaching, or leading a team/project.
• Fluent in English, both spoken and written.

Responsabilités

• Own, guide, and deliver legal representative services for clients in the IVD sector, from strategic guidance on country-specific documentation to high-level reviews ensuring completeness and compliance.
• Submit client applications and notifications for IVD performance evaluation studies to National Competent Authorities and/or Ethics Committees, including substantial modifications, study halts, terminations, or closures.
• Act as the single point of contact for all communications between clients and authorities, and follow up on questions or remarks from authorities.
• Collaborate with sponsors to ensure correct and timely reporting of reportable adverse events.
• Present regulatory arguments in a clear, structured, and audience-tailored way, making autonomous decisions and escalating only major issues.
• Track and monitor submission requirements for IVD performance studies across multiple countries, and share regulatory intelligence with the team.
• Ensure the high-quality, compliant, and timely delivery of projects in line with scope and budget.
• Coordinate the work of the team and support team members in the day-to-day delivery of projects.
• Provide technical support to the team and act as the first point of escalation for project- and team-related matters.
• Mentor, coach, and support the development of team members' skills and competencies.
• Support the onboarding of new employees and foster a culture of collaboration and knowledge sharing.
• Support resource planning, prioritization, and workload balancing within the team.
• Collaborate with management to ensure effective project delivery and team development.
• Build and maintain long-term client relationships as a trusted advisor, proactively addressing client needs and contributing to client satisfaction.
• Support Sales and Business Development with regulatory expertise during client calls, visits, and proposals, identifying opportunities to expand collaboration.
• Represent QbD Group externally at conferences, workshops, and meetings, reinforcing the company's brand and expertise.
• Lead or contribute to internal regulatory initiatives and process improvements.

Connaissances

Regulatory Affairs

Project Coordination

Team Leadership

Client Advisory

English Proficiency

Formation

Master's degree

Description du poste

QbD Group in Belgium is seeking a Senior Consultant to lead Legal Representative Services for IVD clients, combining regulatory strategy with team leadership.

You will own submissions, coordinate multi-country activities, mentor the team, and build strong client relationships while representing the company at industry events.

A Master’s degree and 8+ years of regulatory affairs experience are required; fluent English is essential.