Excellent command of the regulatory environment relating to medicaldevices (EU MDR 2017/745,..Drafting and monitoring regulatory authorisation dossiers for software medicaldevices (updates to existing products,..
new products) Managing relations with the competent authorities in the company's various medical device distribution zones At least 2 years' experience in regulatory affairs in the field of medicaldevices...
Proven experience with FDA and 510(k) submissions Engineering degree or university diploma (Bac5) Excellent command of the regulatory environment relating to medicaldevices (EU MDR 2017/745,..
and will participate in their development by contributing your knowledge of quality management systems and the regulations governing the marketing of medicaldevices...
and will participate in their development by contributing your knowledge of quality management systems and the regulations governing the marketing of medicaldevices...
Quality and Marketing departments to understand the characteristics of the products being developed Define a regulatory strategy in line with the company's sales and R&D policy Providing operational support to all departments to ensure that products comply with regulatory and standards req..
