Senior Consultant Legal Representative Services | Team Lead

ph3Senior Consultant Legal Representative Services | Team Lead /h3pLocation: Hybridbr/Type: Full-time /ppJoin 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. /ppIn 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. /ppThis is an opportunity for an experienced regulatory professional who is ready to expand their role to include responsibility for people, projects, and client collaboration. /ph3What you’ll be doing /h3pbLegal Representative Regulatory Services /b /pullipOwn, 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; /p /lilipSubmit 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; /p /lilipAct as the single point of contact for all communications between clients and authorities, and follow up on questions or remarks from authorities; /p /lilipCollaborate with sponsors to ensure correct and timely reporting of reportable adverse events; /p /lilipPresent regulatory arguments in a clear, structured, and audience-tailored way, making autonomous decisions and escalating only major issues; /p /lilipTrack and monitor submission requirements for IVD performance studies across multiple countries, and share regulatory intelligence with the team; /p /lilipEnsure the high-quality, compliant, and timely delivery of projects in line with scope and budget. /p /li /ulpbTeam Leadership /b /pullipCoordinate the work of the team and support team members in the day-to-day delivery of projects; /p /lilipProvide technical support to the team and act as the first point of escalation for project
- and team-related matters; /p /lilipMentor, coach, and support the development of team members' skills and competencies; /p /lilipSupport the onboarding of new employees and foster a culture of collaboration and knowledge sharing; /p /lilipSupport resource planning, prioritization, and workload balancing within the team; /p /lilipCollaborate with management to ensure effective project delivery and team development. /p /li /ulpbClient Business Support /b /pullipBuild and maintain long-term client relationships as a trusted advisor, proactively addressing client needs and contributing to client satisfaction; /p /lilipSupport Sales and Business Development with regulatory expertise during client calls, visits, and proposals, identifying opportunities to expand collaboration; /p /lilipRepresent QbD Group externally at conferences, workshops, and meetings, reinforcing the company's brand and expertise; /p /lilipLead or contribute to internal regulatory initiatives and process improvements. /p /li /ulh3What you bring /h3ullipMaster's degree in Sciences, Biomedical Sciences, Medicine, Engineering, or Technology; /p /lilipMinimum 8 years of relevant experience in Regulatory Affairs for IVD and Medical Devices; /p /lilipProven experience with IVD legal representative responsibilities and submission procedures is a strong plus; /p /lilipDemonstrated experience in managing complex projects and advising clients; /p /lilipExperience in coordinating the work of others, mentoring, coaching, or leading a team/project; /p /lilipFluent in English, both spoken and written; /p /lilipStrategic, risk-based regulatory thinking with strong stakeholder and expectation management skills; /p /lilipExcellent communication and organizational skills, with the ability to set priorities; /p /lilipIndependence, accountability, and strong problem-solving skills; /p /lilipComfortable working in an international, client-facing consulting environment. /p /li /ulh3What’s in it for you? /h3pbMake a real impact: /b Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices /ppbGrow within a community of experts: /b Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise. /ppbBuild a meaningful career: /b As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. /ppbA fair, competitive package: /b

We offer
tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued. /ph3Who you are /h3pOur culture is driven by values If this sounds like you, you’ll fit right in: /pullipYou’re bresilient /b and tackle challenges with a positive mindset /p /li