Senior Consultant Legal Representative Services | Team Lead

Senior Consultant Legal Representative Services | Team Lead

Location: Hybrid
Type: Full-time

Join our Legal Representative Services team as a Senior Consultant and combine expert regulatory work for clients in the IVD sector with a Team Leader role.

In this role, you act as a trusted advisor and single point of contact for clients, owning the delivery of high-quality legal representative services and submission packages, while also coordinating the team, supporting its development, and sharing your knowledge.

This is an opportunity for an experienced regulatory professional who is ready to expand their role to include responsibility for people, projects, and client collaboration.

What you’ll be doing

Legal Representative & Regulatory Services

• 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.

Team Leadership

• 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.

Client & Business Support

• 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.

What you bring

• Master's degree in Sciences, Biomedical Sciences, Medicine, Engineering, or Technology;

• Minimum 8 years of relevant experience in Regulatory Affairs for IVD and Medical Devices;

• Proven experience with IVD legal representative responsibilities and submission procedures is a strong plus;

• Demonstrated experience in managing complex projects and advising clients;

• Experience in coordinating the work of others, mentoring, coaching, or leading a team/project;

• Fluent in English, both spoken and written;

• Strategic, risk-based regulatory thinking with strong stakeholder and expectation management skills;

• Excellent communication and organizational skills, with the ability to set priorities;

• Independence, accountability, and strong problem-solving skills;

• Comfortable working in an international, client-facing consulting environment.

What’s in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local m