Regulatory Affairs Technician

Requirements:

At least 3 years’ experience in Regulatory Affairs with high-risk medical devicesEssential ability to work well under deadlines pressure, Ability to manage several projects and tasks simultaneously.Strong knowledge of regulatory requirements for medical devices: biocompatibility, sterility, stability, risk management, clinical evaluation, PMS, SSCP, PSUR.

Tasks:

Preparation and Product Technical Documentation according to MDR requirements. Preparation of product dossier for registration in different countries. Deal with Notified Body and Competent Authorities to successfully achieve product certification and registration. SOP development and maintenance in compliance with regulatory and ISO 13485:2016 requirements Collaboration in Regulatory projects and support cross-functional teams through different company sites Ensure product compliance with regulatory requirements in all countries where product is marketed Participate in Notified Body audits and Competent Authorities inspection when necessary