Jobs at QbD Group

Lead strategic business development for MedTech (Medical Device/IVD) clients across Europe. Build and manage long-term client relationships, identify commercial opportunities from regulatory trends, run consultative sales with senior stakeholders, maintain accurate CRM pipeline, win mid-size and large accounts, represent the company at industry events, and collaborate with consultants and internal teams to deliver solutions.

Provide authorised representative services for medical devices, IVDs and biotech products across Europe, UK and Switzerland. Manage regulatory notifications/submissions, liaise with competent authorities and clients, handle incident reporting, store project documentation, supervise junior colleagues, and perform project management tasks including planning, budgeting, invoicing and stakeholder communication.

Own the full sales cycle in the Dutch life sciences market: identify leads, build and expand client relationships, manage customer needs with HR and consultants, propose tailored solutions, maintain accurate CRM records, and grow a professional network across clinical, regulatory, quality, and commercial functions.

Lead billing operations and a team of three, manage full-cycle invoicing and revenue recognition in NetSuite, own the O2C process and ERP change requests, coordinate integrations for acquisitions, reconcile revenue accounts, and drive process improvements across the international finance organization.

Ensure robust Quality Management Systems in GMP-regulated environments. Support CAPAs, deviations, change controls, complaints, and quality events. Perform QA batch record review and support material/batch release. Ensure GMP/regulatory compliance, contribute to audits and inspection readiness, collaborate with stakeholders to drive continuous quality improvements and optimize quality systems.

Lead development, implementation and continuous improvement of the Clinical Quality Management System. Manage document control, CAPA, complaints, audits/inspections, supplier and change management, risk assessments, training, KPIs, software validation, and business continuity to ensure regulatory compliance (GxP, GCP, ISO). Collaborate with global stakeholders to drive quality performance and continuous improvement.

Entry-level role supporting quality, qualification and validation activities across pharma, biotech and medical device clients. Under mentorship, contribute to risk management, validating procedures/systems, improving quality management systems, and supporting technology transfer and new product launches.

Support toxicology team by reading and reviewing scientific reports, managing bibliographic databases, preparing PDE and OEL reports and toxicological assessments, writing reports, and attending client and project meetings in an international consulting environment.

Lead and grow the Toxicology Business Unit: deliver toxicology consulting projects, ensure scientific and regulatory quality, manage operations, support proposals and client engagement, and help shape the service portfolio and market positioning.

Lead planning, execution, and governance of clinical performance studies for IVD devices. Manage high-value projects and the project portfolio, support study coordinators, implement PM tools and templates, own budgets and financial negotiations, drive risk mitigation, stakeholder communication, and continuous improvement across cross-functional, global teams.

Author and verify nonclinical and clinical sections of registration dossiers and CTD Module 1 (Product Information); perform gap and regulatory analyses; assess market introduction and OTC switch options; prepare proposals and perform basic project management under senior supervision.

Provide first-line B2B customer support and guide clients through implementation of e-labeling software. Advise on quality systems, regulatory compliance, security, vendor management and validation. Collaborate with cross-functional stakeholders, analyze client information, contribute to service improvements, and support client success while developing into technical or project roles.

Support clients to achieve Annex 1 sterile manufacturing compliance by providing hands-on expertise in isolators, RABS, cleanroom design and qualification, aseptic techniques, process validation, contamination control (CSS plans), and environmental monitoring programs.

Provide hands-on GMP quality assurance support across pharma/biotech/MedTech projects: batch review and release, deviations/CAPAs, change controls, sterile manufacturing exposure, audit/inspection support, and stakeholder communication while progressing toward QP responsibilities.

Perform on-site and remote GxP/ISO 13485/MDR/IVDR audits worldwide, produce and follow up audit reports, provide corrective recommendations, support clients in remediation, and maintain up-to-date regulatory knowledge.

Certified Qualified Person (QP) to support GMP-regulated pharma and biotech projects. Duties include batch certification and release, GMP oversight, reviewing deviations/CAPAs/change controls, audit and inspection support, sterile manufacturing oversight, stakeholder collaboration, and driving quality system improvements across clients.

Lead and coordinate clinical trials ensuring subject safety, protocol and regulatory compliance (GCP/ISO). Oversee data quality, study documentation, budgets, vendor management, recruitment/retention, timelines, and stakeholder communication.

Lead business development across China for life sciences clients (Medical Device/IVD, Pharma/Biotech). Identify prospects, build networks and partnerships, create proposals and maintain a sales pipeline, collaborate with internal experts and marketing, and localize materials for the Chinese market to drive strategic, long-term engagements.

Perform QA activities in a GMP life‑sciences environment: maintain quality records, perform risk assessments, investigate deviations and CAPAs, review batch records and support batch release, support audits/inspections, and collaborate cross‑functionally to ensure compliance and product quality throughout development and production.