QbD Group
Consultant Authorised Representative Services
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Consultant Authorised Representative Services
đź“Ť Location: Hybrid
đź•“ Type: Full-time
QbD Group offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD. Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). Our RA division has a strong international presence with over 100 colleagues in Belgium, the Netherlands, the UK, Spain, Poland and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa).
We are looking for a Consultant to join our Authorised Representative Services team.
💡 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 market regulations — because your contribution deserves to be valued.
🏢 What you’ll be doing
- Correct and efficient execution of Authorised Representative tasks and responsibilities, including but not limited to:
- Providing support to clients to ensure their documentation packages are complete by providing guidance and advice on the documentation needed for Europe, UK and/or Switzerland and by performing a high-level review of the documentation provided by the client.
- Submit notification packages to the respective Competent Authorities.
- Follow-up with client in case of questions/remarks from the National Competent Authorities.
- Submission of changes to the National Competent Authorities.
- Act as single point of contact for all communications from the National Competent Authorities with the legal manufacturer.
- If reportable incidents or serious incidents occur, cooperate with the manufacturer and National Competent Authorities to ensure correct reporting is done in agreement with service-related procedures.
- Communicate with the Client and Competent Authorities in a correct, accurate, quality-minded and timely manner and in agreement with service-related procedures.
- Store client and project related documentation in an organised, accurate and quality-minded manner and in agreement with service-related procedures.
- Dare to make decisions of which the outcome can't always be assessed, and only verifying major decisions with others (e.g. manager). Not putting off decisions. Presenting arguments in a clear and structured way and taking into account the opinions of others. Adapting arguments and communication style to the target audience. Intervening promptly when an urgent problem arises.
- Supervise and guide (coach) more junior team members. Offer active help and support to colleagues to complete their tasks and achieve results. Match tasks to the capabilities of each colleague. Gives honest and constructive feedback and makes others feel involved.
- In case of problems, coming up with practical, workable solutions and translating them into a concrete action plan. Escalating issues when needed.
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- Within the role you must be able to take up all or some of the responsibilities associated with project management, including but not limited to:
- Ensuring correct, efficient and timely execution of assigned tasks and responsibilities, with minimal supervision and in an independent, yet collaborative manner, without compromising on quality.
- Organising project related meetings (internal and external).
- Creating detailed project plans using company provided tools.
- Efficient management of projects, defining the scope, understanding project risks, assigning team members to specific tasks, managing team members and monitoring project deliverables, timelines, and budget.
- Professionally liaise with colleagues as well as the client to communicate and resolve potential issues.
- Act as project manager for some projects and as such monitor progress, time spent versus budget as well as money spent versus budget. Approve project associated incoming invoices associated to costs incurred and ensure accuracy of all outgoing invoices. Escalate where necessary.
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- As part of the Authorised Representative Service team you must contribute to ensuring the team remains up to date of the requirements for notification of manufacturers, new devices or changes to existing devices to the National Competent Authorities (BE, UK and Swiss) and support in ensuring the broader authorised representative team is kept informed of changes and requirements. You support members within the organisation with Representative service specific questions and can act as a subject matter expert and point of reference.
đź’Ş What you bring
- You have a higher degree in life science or technology.
- You have relevant experience in IVD, MD or biotech.
- You have relevant experience in regulatory submissions.
- You have relevant experience in working with multiple clients.
- You have strong attention to detail.
- You have strong written and verbal communication skills.
- You have good organizational skills and an analytical mindset.
- You enjoy working in an international environment.
🫵 Who you are
Our culture is driven by values. If this sounds like you, you’ll fit right in:
- You’re resilient and tackle challenges with a positive mindset.
- You’re curious and always up for learning something new.
- You have a no non-sense approach honest, clear, respectful.
- You’re innovative and bring ideas, not just opinions.
- And above all, you’re serious about your work, but not too serious about yourself.
✨ About us
We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.
We believe in JPEG:
- Joy
- Partnership
- Going the Extra Mile
- Getting Things Done
You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.
📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.
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