QbD Group

Consultant

• Provide specialist regulatory consulting services directly to customers in the IVD sector
• Support clients in defining their regional and global regulatory strategies, submission pathways and lifecycle planning
• Anticipate regulatory challenges across the product lifecycle and assess their regulatory, clinical performance and compliance impact
• Monitor regulatory developments and translate changes into practical advice for clients and internal stakeholders
• Deliver client training sessions, workshops and presentations on regulatory and clinical topics
• Act autonomously in complex decision-making, supporting and defending regulatory positions while escalating as appropriate
• Own, design, author and review regulatory and scientific documentation for IVDs

Senior Consultant, RA IVD

Attorney

• Correct and efficient execution of Legal Representative tasks and responsibilities
• Submit client application/notification packages to Competent Authorities and/or Ethics Committees
• Act as single point of contact for communications from authorities
• Monitor progress, time and money spent versus budget on projects
• Provide support to the Business and collaborate with internal teams

Senior Consultant, RA IVD

Legal Consultant