Control expert - assessor

Overview

The role of control expert - assessor involves participating in joint assessments in the field of medical devices and related activities within the Directorate-General for Health and Food Safety.

Key Responsibilities

• Participate in joint assessments of conformity assessment/notified bodies in the area of medical devices.
• Engage in related activities of the medical devices team, including liaison with the corresponding policy unit and organisation of training for Member States’ experts.
• Contribute to work in other areas covered by the unit on a needs-basis.
• Carry out up to 10 on-site assessments per year, lasting usually 1 week or slightly more.

Required Experience

• At least 5 years of work experience in medical devices’ regulatory aspects, including clinical investigations, classification/borderline cases, vigilance and compliance.
• Of which, at least 3 years of work experience must refer to medical devices technical documentation assessments and/or clinical evaluation reviews.
• Work experience participating in audit teams carrying out audits of medical devices manufacturers would be desirable.
• Candidates having participated as assessor/national expert in joint assessment teams assessing notified bodies/conformity assessment bodies in the area of medical devices would have an advantage.
• Work experience could have been gathered at different levels, for instance, in a national/international authority/regulator, designating authority, notified body and/or manufacturer.

Qualifications

• Completed university studies of at least 3 years attested by a diploma.
• Graduate in a discipline such as bio-medical engineering, medicine, pharmacy, bio-medical sciences, veterinary science, or equivalent.

Other Details