PpbWHO WE ARE /b /ppAs a laser technology company, we innovate to improve life quality of people with one consistent belief: creating new perspectives for future generations by evolving with our most inner attitudes. Cause there is always a way to make life better. And this way finds its answers in our daily actions. Our primary goal is to increase our positive impact on the world through more than 30.000 installed lasers in 150 countries. Our 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. /ppWe believe in sustainability, in responsibility; we are firm supporters of interpersonal relationships based on mutual listening, between people who know how to leverage creativity in search of solutions. /ph3ABOUT THE ROLE /h3pWe are looking for a Regulatory Affairs Specialist to join our team and support global registrations of medical lasers, optical fibers and related accessories. /ph3MAIN RESPONSIBILITIES /h3pAs a Regulatory Affairs Specialist, you will play a key role in the following activities : /pulliContribute to international registrations of medical lasers, optical fibers, and related accessories; /liliParticipate in defining regulatory strategies for assigned projects; /liliPrepare documentation and application dossiers; /liliServe as a point of contact with Regulatory Authorities and Regulatory Partners (Distributors, Consultants, etc.); /liliSupport the review process by responding to reviewers’ questions and resolving any gaps; /liliManage and coordinate post-approval activities, such as design changes, product configuration updates, and license archiving; /liliPrepare periodic communications to be submitted to international Authorities to maintain registrations; /liliEvaluate customer complaints to determine the reportability of events in accordance with specific legal and regulatory requirements; /liliSupport the digitalization of regulatory processes, contributing to the development of electronic document management systems; /liliAssess the regulatory impact of design changes, planning and managing notifications to certification and Regulatory Bodies, and handling potential license amendments; /liliTake part in inspections focused on regulatory matters. /li /ulpbWHO WE ARE LOOKING FOR /b /ppTo successfully carry out the required activities, we are looking for candidates with : /pulliDegree in scientific disciplines; /liliAt least 3 years of experience in regulatory affairs, preferably within the medical device industry. Experience with international registrations is highly desirable; /liliFluency in both English and Italian; /liliAbility to collaborate effectively within team; /liliStrong autonomy in achieving goals and delivering results; /liliEnjoy engaging with people from diverse cultural backgrounds; /liliDriven by curiosity and passionate about new challenges. /li /ulpbTechnical Skills Required : /b /pulliExperience in drafting technical files and non-European submissions; /liliKnowledge of medical device regulations (MDD, MDR, 21 CFR, 21 CFR Ch. I Subpart J, MDSAP, ISO 13485); /liliFamiliarity with ISO 10993, ISO 14971 standards and application principles of technical standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366; /liliExperience in complaint evaluation and regulatory impact assessment of design changes; /liliTrack record of direct interactions with Notified Bodies and Competent Authorities; /liliKnowledge of the eSTAR method for 510(k) submissions (FDA PreMarket Notification); /liliExperience with cleaning, disinfection, sterilization, and reprocessing of medical devices; /liliPrevious experience with laser technology will be considered a plus. /li /ulpDoes this sound like the right opportunity for you? Apply now! /p /p #J-18808-Ljbffr