Medical Device & Regulatory Affairs Manager

10/09/21

Location

Fotografielaan 5, Wilrijk, Belgium

Function type

bediende

Vacancy

Company

 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. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. They help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They are also authorized representatives for non-EU manufacturers and off a unique solution for e- labeling,  currently used by multi-billion-dollar medical device and IVD companies. From their offices in Geel, Eindhoven, Turin and other international locations, they serve more than 250 customers worldwide.

What are your responsibilities?

 In general

  • Leadership of Authorised Representative service

  • Establish, implement and maintain the Quality System processes under category “Authorised Representative” in agreement with regulatory requirements

  • Correct and efficient execution of Authorised Representative tasks and responsibilities, including relevant communication to the competent authorities

  • Contribute to achieve financial and other objectives (KPI). Communicate KPI to team members

  • Integrate information security controls within the processes for Authorised Representative service

  • Ensure that the technical documentation of clients is up to date

  • Protecting the client’s regulatory interests

For Authorities

  • Advise Authorised Representative Director and Personal Responsible for Regulatory Compliance in decision taking on Incident and FSCA reporting

  • Execute Incident and FSCA reporting

  • Make technical documentation available upon demand of competent authority

  • Define and communicate information security responsibilities and duties for employees, contractors and other third parties regarding Authorised Representative service

  • Perform notifications of IVDs and MDs

 

Who are we looking for?

  • Master of engineering degree in sciences or technology

  • Minimum 7 years relevant experience in Regulatory Affairs function or minimum 7 years of experience in IVD, MD or biotech industry

  • 1-3 years of leadership experience

  • Language: English

  • You enjoy working in an international environment. You are organized, an effective communicator, proactive, flexible and customer focused.

 

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!

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

Job application