Regulatory Manager

Location Leuven area, Belgium
Discipline: Medical Device
Job type: Permanent
Contact name: Christian Steenkamp

Contact email: c.steenkamp@panda-int.com
Job ref: 10622
Published: about 1 month ago

Currently, I am looking for a Regulatory Manager for one of our Medical Device clients in the Utrecht area. The organisation is a developer, manufacturer and supplier of diabetes care devices. Their goal is improving healthcare on an global level.

 

YOUR RESPONSIBILITIES

  • Completely involved with creating strategies and developing plans to make sure that products are compliant when it comes to required documentation and legislation
  • Leading various types of audits among which internal, and distributor audits
  • Lead the team in acting up on these audits, performing CAPA’s and creating tools for compliancy
  • Internal and external audits for the Quality Management System at international locations
  • You will be the Quality point of contact the establishment and maintenance of relationships with internal and external authorities.

 

YOUR PROFILE

  • Bachelor of Life Sciences or related
  • Minimal 3 years of experience within Medical Devices
  • Proven experience in building and maintenance of relationships with internal and external authorities
  • In-depth knowledge of MDR, MDD and FDA
  • Fluent in English and Dutch
  • Team player and good communicator

 

INTERESTED? Please contact for more information by contacting +31 (0)20 20 44 502 or c.steenkamp@panda-int.com