Job Opening

06 April 2018

Job Opening

An inspiring, rewarding and challenging job is waiting for you at Organ Assist. Through our products, we aim to enable more and better quality donor organs to become available for transplantation. More and more hospitals worldwide start implementing our products. Organ Assist has a mission to stay on the forefront of making innovative products and developments available in the life changing field of organ transplantation. We therefore aim to secure our existing market and expand to new markets. To ensure this strategy, we will extend our multi-disciplinary product development and regulatory affairs team and are looking for an enthusiastic new colleague. Do you share our passion to make a difference?

Your function:

Regulatory Compliance Engineer

Your activities:

• You will be responsible for compiling the full technical documentation of our devices and disposable tubing sets.
• You will be responsible for providing compliance of this documentation with EU-MDR and US-FDA requirements.
• You will participate in maintaining the Quality Management System.
• You will secure QA/RA aspects in running research & development projects.

Your profile:

• We are looking for an experienced regulatory compliance engineer with a technical background (e.g. electro-mechanical engineering, biomedical engineering or comparable).
• You have a natural affinity with the medical field.
• Proven experience with the medical device directive and associated standards; experience with FDA is a strong advantage.
• Master of Science (MSc) degree is preferred.
• Proven English communication skills (spoken and written).

Our offer:

• Ability for you to make a difference (i.e. more transplantations, better quality of life for our patients).
• Energetic, dynamic and innovative working environment.
• Office location in Groningen, The Netherlands.
• Competitive working conditions.

Your action:

Send your motivation for this position (incl. Curriculum Vitae) before May 1st 2018 to: info@organ-assist.nl