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Regulatory affairs responsible/manager

Locatie

Sint-Niklaas

Bedrijfsprofiel

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.

Functieomschrijving/taken

Aptec offers you a broad regulatory role with a focus on ‘Product RA’

Profiel kandidaat

  • 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.

Arbeidsvoorwaarden

By joining Aptec, you will be part of solid business with a reference in Turbidimetry. Aptec employees appreciate their rich job content and the great deal of independence within their job. In an open, informal and dynamic work environment you will be collaborating with their team. To support this collaboration and to support personal growth of all team members Aptec offers their employees the opportunity to develop their knowledge, skills and talents. Working hours at Aptec are very flexible, starting between 7h-10h. You will receive a fulltime contract with a market conform salary.

Contactpersonen

Nele Geusens, Recruitment Specialist
T: +32 497 57 08 94
E: geusens@themagroup.be

Tagcloud Regulatory affairs responsible/manager

Regulatory affairs-IVDR-diagnostics-serum-proteins- pharmacy-clinical chemistry-turbidimetry
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Duitsland

Merowingerplatz 1
40225 DUESSELDORF
E-mail

België

BioVille, Agoralaan
Building A bis
B-3590 DIEPENBEEK
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Pivot Park Kloosterstraat 9 
5349 AB OSS
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Nederland

Odiliastraat 92
5401 ZZ UDEN
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