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.
Sales of our existing products and services is growing rapidly and we aim to launch new products every year. All our products are manufactured in-house and we are scaling up our manufacturing efforts to meet market demands, while medical device regulations are continuously chaining. To be able to fulfill all rapidly changing and complex regulatory requirements we are looking for a team oriented, result driven and ambitious
In this exciting role you will provide the company with the needed Regulatory knowledge, guidance and advice. You will be the strategic manager of our Regulatory Specialists and will act as an entrepreneur by making new technical files and getting old files up to date with new 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.
- A bachelor or master degree in life sciences/medical field.
- Proven experience in managing positions within European Regulatory Affairs within medical device or IVD industry.
- Solid Technical knowledge of EU IVD Directive and IVD Regulation or equivalent in Medical Devices Directive/Regulation.
- Excellent written and verbal communication skills in English. Dutch is preferred as well.
- A creative entrepreneurial mindset.
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 RA Manager appeal to you and do you think that you can contribute to the success of our organization? Email your application to firstname.lastname@example.org.
Acquisition following this vacancy is not appreciated.