JOBS

Back

Authorised Representative Specialist (H/F/X)

January 29th 2024

QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient. With more than 450 quality experts, QbD is your partner for advice and support.

Mission Description

In general : 

  • 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. 

For Authorities : 

  • 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

Candidate profile

  • 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.

Offer

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!

Contact Details

Send us you CV and motivation letter and who knows, we might welcome you soon!

https://qbdgroup.com/en/jobs/vacancies/authorised-representative-specialist/