QA/RA manager

Location Netherlands
Discipline: Medical Device
Job type: Permanent
Contact name: Christian Steenkamp

Contact email: c.steenkamp@panda-int.com
Job ref: 16484
Published: about 2 months ago
I’m currently looking for a QA/RA Manager (IVD) for a dynamic organization specialized in oncology, based in the Randstad. This company is on a mission to change cancer diagnostics and treatment and thereby improving chances of survival and quality of life of patients.
 
As QA/RA Manager you’ll have a leading role in implementing and maintaining the QMS, support the registration of the IVD and maintain Technical files. You’ll work together with leading partners and key opinion leaders in the field to develop state-of-the-art techologies.
 
RESPONSIBILITIES
  • Implement and maintain the QMS compliant with the ISO13485/ 21CFR820
  • Support development the registration of the PCR and Biochip assays for in-vitro diagnostic in line with the regulations
  • Maintain technical files to ensure CE
  • Work closely together internally with the R&D Project Leaders, Director Clinical Affairs and the IVD Development Manager
  • Risk Management, Audits, Document Control, Reviewing validation documents, Deviation- and CAPA Management.
  • Provide training on Quality
 
YOUR PROFILE
  • At least a Bachelor’s degree in a relevant area
  • 3+ years’ experience with IVD product development (ISO13485/ 21CFR820)
  • Experience with IVD regulations, FDA and CE Marking experience is a plus
  • Strong communicator in English. Dutch is a plus
  • Hands-on, Quality minded, Pragmatic, Flexible and Independent
 
ORGANISATION AND OFER
You’ll join a Dutch scale-up company that is on a mission to make a significant impact by improving the chances of survival and quality of life of cancer patients.
You’ll be part of an exciting, open work environment where new challenges are faced every day and you’ll have the opportunity to make a significant contribution. At the same time, they offer opportunities for personal and professional growth and development.
You can expect an attractive salary and benefits and you’ll have a lot of freedom in the job.
 
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or c.steenkamp@panda-int.com