Regulatory Affairs Specialist - Almere

Vacancy information

Publication date:January 22 2021
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / RA Officer

Organization

For a fast-growing organisation that focuses on the development, production, and commercialisation of class III medical devices, we are currently looking for a Regulatory Affairs Specialist. As a Regulatory Affairs specialist play a key part in making sure all products and the company are compliant.

Function

In this role, you maintain compliance with regulatory authorities. To enable this you gather and assemble information that is needed for submissions in accordance with global regulations and guidelines. After submission, you plan and reply to regulatory agencies for questions and other correspondence. With this, you contribute to all risk and safety assessments. Other tasks are being part of solutions for a variety of complex issues that are product or production-related.

Requirements

We are looking for someone with the following skillset:

  • Experience in ISO 13485
  • Knowledge of the MDD and MDR
  • Working experience with risk management
  • Fluent in Dutch and English

Offer

The organisation can offer you the following:

  • Market competitive salary
  • Pensionplan
  • Yearly bonus

Application

Quintes Hamer

Associate

+31(0)23-7548660
+31(0)6-82100758
q.hamer@qtcrecruitment.com

Apply

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