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40 hours - GTX medical

Regulatory Engineer Go-2

Job details

Full-time

The Regulatory Engineer will be part of the Go-2 project team developing an active implantable medical device (AIMD) with the aim to let paralyzed people walk again.

Tasks and Responsibilities:

• Provide general Regulatory Documentary support to the development team for the creation of a Design History File,

• Interact with teams to provide regulatory guidance regarding the design, development, evaluation, labelling, and marketing of products;

• Packaging and Labelling activities

• Creation of submission File according to GSPR checklist. Cooperate closely within the Regulatory team that is supervising the creation of the full DHF

• Ongoing gap assessment of the current regulatory activities versus newly to be published guidance related to the MDR.

• Traceability assessments for demonstrating regulatory compliance to applicable standards (14708-1, 14708-3 …)

• Work with the engineering team for FMEA execution as per ISO 14971 as part of technical file updates.

• Participates in the planning of product safety and performance standards with third-party laboratories

• Creation of regulatory compliance documentation (e.g. Test Report Forms) and interaction with test houses.

You have a:

• Strong understanding of Regulatory processes in MedTech: Medical Device Directive or Medical Device Regulation

• Strong understanding of translating regulatory standards into compliance reports

• Strong affinity with the use of traceability tools and fast learner on how to use them correctly.

• Understanding of Documentation requirements for creation of DHF

• Strong drive to be precise and thriving for consistency.

• Experience in medical domain and ISO quality management.

Function requirements:

• You have a Bachelor or Master’s degree in Engineering, or a similar degree in Quality or Regulatory

• Relevant industry experience, preferably with active implantable medical device;

• You are a high energy, self-motivated, pro-active individual able to work in a diverse team within a startup company; you are willing to help your colleagues.

• You are fluent in English. This is our company language. Mastering of French and/or Dutch language is highly appreciated.

Job details
  • Regulatory Engineer
  • High-Tech Start-Up Eindhoven
  • Class III Medical Device System
  • European international environment
  • Multidisciplinary Engineering Team
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