Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations.
Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). We are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion-dollar medical device and IVD companies.
What do we expect from you as an Authorised Representative Specialist?
- Correct and efficient execution of Authorised Representative tasks and responsibilities, including relevant communication to the competent authorities.
- Ensure that the technical documentation of clients is up to date
- Protecting the client’s regulatory interests
- Coordinate and execute Authorised Representative projects:
- High level review of customer documentation
- Notifications of devices or device changes to the relevant Competent Authority
- Remain up to date of Medical Device and IVD legislation (Medical Devices and In Vitro Diagnostics Ordinances) and ensuring the AR team is kept informed of changes and requirements.
- Execute Incident and FSCA reporting
- Perform notifications of CE and UKCA marked IVDs and MDs
- Make technical documentation available upon demand of competent authority after approval by Management
- Internal and external communication on the assigned projects
Who are we looking for?
- You have a Master or engineering degree in sciences or technology
- You preferably have a first experience in regulatory affairs in IVD, MD or biotech industry or a strong interest in this field
- You have excellent English verbal & written communication skills
- You enjoy working in an international environment. You are a strong communicator, a decision maker and administratively skilled. You are organized, flexible and customer focused
- A true QbD’er can be recognised by the following qualities:
- Resilient: Your strong and positive attitude helps you overcome any challenge
- Hungry for knowledge: You are always open to learning
- No BS mentality: you can be straightforward in a respectful way
- Innovative: You are constantly looking for new and better solutions
- (Not too) serious: your job is serious, but you don’t take yourself too serious.
What does Qarad, part of the QbD group, offer you?
The QbD group is a healthy company with a strong growth and international ambitions. In addition to a very attractive salary package, we can offer you the following advantages:
- The chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics
- A company with a clear strategy and ambition
- The opportunity to use and develop your skills in a world class team of specialists
- Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise
- Thanks to our flat organization, we have short communication lines
- In short… We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Send us you CV and motivation letter and who knows, we
might welcome you soon!