Medical Device Expert

Harefield, England, United Kingdom · Regulatory Affairs

Description

MAIN PURPOSE:

The Medical Devices Expert is responsible for activities requiring in-depth knowledge of regulations and regulatory requirements in relation to Medical Devices post CE approval, as well as assessments of Medical Devices and In-vitro Diagnostic and Active Implantable Medical Devices (if appropriate) in Due diligences, this includes:

Providing Subject Matter Expertise in conjunction with due diligence of business opportunities

Interpret regulations and make recommendation on the implementation and the preferred regulatory strategy

Participate in external and internal audits to ensure the successful re-certification of products

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Requirements

INDIVIDUAL REQUIREMENTS AND COMPETENCIES

Qualifications

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