Regulatory affairs responsible/manager
APTEC Diagnostics nv, founded in 1992, is a manufacturer of high quality, stable Turbidimetric reagents to measure serum proteins in human plasma or urine. With over 20 years of experience and solid business they are considered to be a reference when it comes to Turbidimetry. Their current portfolio lists more than 40 reagents. They are specialized in customized solutions for ready to use reagents, antibodies, calibrators and controls. Packed in bulk format, general kit format (applicable for clinical chemistry analyzers in general) or system packs (which are designed for a specific analyser). They highly value good customer service including good communication and training. They have in-house instruments and an extensive list of applications on open instruments currently present on the market.
To maintain and obtain regulatory approval and license in the global market for their diagnostic products and thereby guarantee continued sales eligibility, they are looking to strengthen their Aptec team with a Regulatory Affairs Responsible/Manager.
- You hold a master degree in medicine, pharmacy, engineering or another relevant scientific discipline. Master degree in Clinical Chemistry is a plus.
- You have at least 1 year of professional RA experience or experience in quality management systems relating to in vitro diagnostic medical devices and have at least 5 years of professional experience in general.
- You have an eye for details combined with excellent stress & time management skills.
- You have excellent communication skills in both Dutch and English.
- You are a strong project worker for whom flexible planning and getting deadlines are holy.
- Someone who thrives on organizing chaos and filling in blanks in a very independent manner (discerning what’s important and what’s not).
- You have an inquisitive personality with the necessary education to understand and weigh potential risks properly.
- You are a smart communicator, both empathic for others’ concerns and strong willed for your own.
T: +32 497 57 08 94