• Draft regulatory registration files and ensure coordination with international Notify bodies
• Participate in marketing declarations and draft technical files (CE marking)
• Advise and assist the departments concerned on regulatory aspects (R&D, production, quality, marketing, sales, etc.); provide the applicable standards
• Dealing with technical questions from health authorities
• Check the conformity of commercial documentation and media subject to advertising control
• Participate in the risk management review
• Be proactive on the regulatory strategy (product classification, country constraints).
• Ensure the proper application of the European regulation on medical devices (MDR 2017-745)
• Required to have good expertise of MDR 2017-745, ISO14971 and ISO13485
• Minimum 5 years of experience within Regulatory Affairs/Medical Devices