PstrongWHO WE ARE /strong /ppbr / /ppAs a stronglaser technology company /strong, we innovate to improve life quality of people with one consistent belief:br / creating new perspectives for future generations by evolving with our most inner attitudes. /ppstrongCause there is always a way to make life better. /strongAnd this way finds its answers in our daily actions. /ppbr / /ppOur primary goal is to increase our positive impact on the world through more than 30.000 installed lasers in 150 countries. /ppbr / /ppOur company is constantly growing, in constant evolution not only in the search for innovation but above all for People and Talents who join our path. /ppbr / /ppWe believe in sustainability, in responsibility; br / we are firm supporters of interpersonal relationships based on mutual listening, between people who know how to leverage creativity in search of solutions. /ppbr / /ppstrongABOUT THE ROLE /strong /ppbr / /ppWe are looking for a strongRegulatory Compliance Specialist /strong to join our Regulatory Affairs Team and support activities to strongensure medical devices compliance /strongwith applicable regulatory requirements by drafting user manuals in line with relevant standards and creating up-to-date technical documentation to be submitted to notified bodies and competent authorities. /ppbr / /ppstrongMAIN RESPONSIBILITIES /strong /ppbr / /ppAs a strongRegulatory Compliance Specialist, /strong you will contribute to the following core activities:br / /pullistrongIdentify /strong and strongevaluate compliance requirements /strong for new and existing products or features. /lilistrongCooperate with cross-functional teams /strong to ensure compliance during the design development. /lilistrongAssess medical device safety /strong by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations. /lilistrongDraft User Manuals /strong that comply with relevant regulatory requirements and medical device standards, manage and identify translations needs. /lilistrongCreate Technical Documentation /strongup-to-date and compliant with respect to the applicable requirements to be submitted to the Auditing organizations and authorities. /lilistrongManage the submission of Technical Documentation /strong to the Notified Bodies by developing necessary materials and addressing queries and possible deficiencies. /lilistrongEvaluate customer complaints /strong to determine the event reportability according to the local law and regulatory requirements. /lilistrongCollaborate during audits /strong and other regulatory body interactions for the topics related to Technical Documentation. /li /ulpbr / /ppstrongWHO WE ARE LOOKING FOR /strong /ppbr / /ppTo successfully carry out the required activities, we are looking for candidates with:br / /pulliA strongDegree in scientific disciplines /strong or a minimum ofstrong 2 years work experience /strong strongin product compliance /strong with specific reference to electromedical devices (Class I, IIa, IIb). /liliFluency in written and spoken strongEnglish /strong and Italian. /lilistrongStrong writing and editing skills /strong with the ability to explain complex concepts in a simple and understandable manner. /liliExcellent strongproject management /strong and organizational skills. /liliStrong strongattention to detail /strong and a commitment to quality. /liliAbility to work effectively in a cross-functional team environment. /li /ulpbr / /ppstrongTechnical Skills Required:br / /strong /pulliKnowledge of EU Regulation 2017/745 (MDR) and Regulation (EU) 2022/2346, technical standard IEC 60601-1 related collateral standard (e.G.:br / IEC 60601-1- 2; br / IEC 60601- 1- 6), the standard IEC 60601- 2- 22, and of IEC 60825- 1. /liliKnowledge of the standards ISO 14971 (Risk Management), ISO 10993 series (Biocompatibility), ISO 11135 (Sterilization), ISO 17664 (Reprocessing). /lilistrongProven experience as a technical writer in the medical device or healthcare industry. /strong /liliProficiency in using graphics software tools (e.G., Adobe Illustrator). /li /ulpbr / /ppstrongDoes this sound like the right opportunity for you? Apply now! /strong /p