Chargé d'affaires Réglementaires Dispositifs Médicaux (H/F)

Description: Job Description As a member of the European Healthcare Regulatory Affairs team, your main responsibility is to ensure full compliance to the European Medical Device Vigilance Process for the Ecolab/Anios Medical Device product portfolio and lead the communication to the affected competent authorities and notified bodies, in particular with the ANSM. You are the Business partner for quality, being the interface between regulatory and quality to ensure that regulatory requirements are properly captured in the QMS and different procedures and defining processes with role and responsibilities across functions You provide regulatory support for Medical Device Teams in case of vigilance situations Act as PRRC, Person responsible for Regulatory Compliance ? for Laboratoires Anios, according to Article 15 of REGULATION (EU) 2017/745 You liaise with notified bodies and competent authorities in your area of responsibility You provide subject matter expertise in compliance audits and inspections You contribute to risk assessments You maintain and share your knowledge Qualifications, Experience, Knowledge & Competencies: Master?s degree in chemistry, biology, toxicology, quality, engineering or any other related field 3 to 5 years work experience in regulatory affairs or quality management systems related to Medical Devices Experienced in dealing with regulatory Agencies / Notified Bodies (ANSM) If not already experienced, ability to develop skills in other regulatory areas other than Medical Devices, such as biocides, cosmetics and human drugs First proven experience in leadership, project management, problem solving and team development skills Ability to respond quickly in emergency situations related to product registration and public health issues (Vigilance Activities) Strong communication skills at executive level Demonstrated ability to influence across a matrix environment with multiple stakeholders and competing priorities, in an international environment Fluent French and English, with good written and verbal communication skills You are rigorous, reactive, proactive, autonomous. You are flexible and organized. The position is preferably based in Lezennes (59).Agree to travel across Europe and possibly other regions Part of the interview will be conducted in English.