We are Wellinq. We develop, manufacture and sell high-quality medical devices. Additionally, we build sensoring equipment that is integrated into our medical devices or finds independent medical and industrial implementation. The accumulated engineering skills and in-house manufacturing capabilities coupled with the go-get mentality of its workforce make Wellinq a thriving specialized enterprise. We will not settle for a mere status-quo. Ceaselessly, we are keeping a watchful eye toward the future. Our customers are located world-wide and sell to thousands of hospitals where doctors save lives using the Wellinq products on a daily basis.
We aim to launch new products regularly. We are scaling up our manufacturing efforts to meet market demands, while medical device regulations are continuously changing. To be able to fulfill all rapidly changing and complex regulatory requirements we are looking for a team oriented, result driven and ambitious
Quality / Regulatory Engineer
Every day you challenge our day-to-day business to improve the quality of the processes and products. You do so by supporting the teams and advising the management on identifying and solving quality issues in a sustainable way. Our production-, engineering, – and development teams will reach out to you for advice and support on quality related issues.
As your expertise is also in the field of Regulatory Affairs, you can expect to be involved in a variety of projects. In this exciting role you will provide the company with the needed Regulatory knowledge, guidance and advice. You will act as an internal specialist by creating new technical files in accordance with MDR standards. You work as a key player in preparing and collecting regulatory submission deliverables for product registrations. You will coordinate the submissions effectively, organize meetings for further alignments with the various stakeholders, and ensure the implementation of country specifics regulatory projects.
You will participate in audits performed by the Notified Bodies and you are the gate keeper of the internal auditing plan and of the improvement plans.
- A bachelor or master degree in life sciences/medical field, with a strong interest in engineering.
- Proven experience within European Regulatory Affairs within medical device or IVD industry.
- Solid Technical knowledge of EU Medical Device Directive and in Medical Devices Regulation (IVD and IVDR also.
- Knowledge of ISO standard related to Medical Devices (ISO 13485)
- Excellent written and verbal communication skills in English, also in technical writing. Dutch is preferred as well.
- A creative entrepreneurial and hands-on mindset.
- Experience on Corrective Action Preventive Action projects
- Internal auditing
- Statistical knowledge is a plus
A challenging position with a commensurate employment package. Wellinq has a pleasant working environment in which professionalism is a priority. Our company offers opportunities for personal development. Place of employment is in Leek (nearby the city of Groningen).
Does the position of Quality/Regulatory Engineer appeal to you and do you think that you can contribute to the success of our organization? Email your application to email@example.com.
First want more information about this vacancy or about Wellinq? Visit our website: www.wellinq.com.
Acquisition following this vacancy is not appreciated.