Technical Document Assessor - Notified Body

The Role

The Notified Body is accredited to certify companies according to the EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR). Reviewing documentation, assessing products, performing quality management system audits and unannounced audits are part of the certification and the Notified Body's department.

As a Technical document Assessor in our department, you will review technical documentation from our customers within the medical device industry around the world. Review of documentation is carried out according to a specific process, including writing reports mainly in English.

We are currently expanding our area and therefore looking for a number of Technical Documentation Assessors. Today we are a growing company eager to optimize our processes, work more efficiently and expand our knowledge and competencies.

As a Technical Documentation Assessor, you can expect to interact, on a frequent basis, with internal and external personnel including our customers, other members of the Notified Body team and management.

The role is permanent and not location specific since you will be able to be home based.

Workplace experience

Minimum four (4) years' professional experience in the field of healthcare products or related activities, i.e.:

• work in medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies work in the application of device technology and its use in health care services and with patients testing devices for compliance with the relevant national or international standards conducting performance testing, evaluation studies or clinical trials of devices  

Minimum two (2) out of these four years shall be in the design, manufacture, testing or use of the device or technology to be assessed.