ABOUT US
We are a European organization recognized as an official Notified Body under Regulation (EU) 2017/745, specializing in verifying the conformity of medical devices with the stringent requirements of the MDR 2017/745 regulation. Our work ensures that medical devices meet the necessary standards for certification and market entry within the European Union.
For our expanding Medical Devices Division, we are seeking an experienced professional to join our team as a Lead Auditor for Active Electromedical Devices (MDR 2017/745).
PRIMARY RESPONSIBILITIES
In this role, you will:
- Conduct audits of manufacturers and, where necessary, their suppliers.
- Assess the technical documentation of assigned medical devices to ensure compliance with MDR 2017/745.
- Oversee certification processes for a diverse portfolio of international manufacturers of active medical devices.
QUALIFICATIONS
Educational Background
- A degree or advanced qualification in scientific fields such as biomedical engineering, bioengineering, physics, electrical engineering, or similar disciplines.
Professional Experience
Candidates should have:
- Significant experience in the active medical device industry, focusing on design, manufacturing, technical documentation, or testing; OR
- Extensive experience with Notified Bodies, including evaluation of technical files and audit activities for active medical devices.
Language Skills
