Requirements: English
Company: Quanta System Spa
Region: Samarate , Lombardy
WHO WE ARE As a laser technology company, we innovateto improve life quality of people with one consistent belief:creating new perspectives for future generations by evolving withour most inner attitudes. Cause there is always a way to make lifebetter. And this way finds its answers in our daily actions. Ourprimary goal is to increase our positive impact on the worldthrough more than 30.000 installed lasers in 150 countries. Ourcompany is constantly growing, in constant evolution not only inthe search for innovation but above all for People and Talents whojoin our path. We believe in sustainability, in responsibility; weare firm supporters of interpersonal relationships based on mutuallistening, between people who know how to leverage creativity insearch of solutions. ABOUT THE ROLE We are looking for a RegulatoryAffairs Specialist to join our team and support globalregistrations of medical lasers, optical fibers and relatedaccessories. MAIN RESPONSIBILITIES As a Regulatory AffairsSpecialist, you will play a key role in the following activities: -Contribute to international registrations of medical lasers,optical fibers, and related accessories; - Participate in definingregulatory strategies for assigned projects; - Preparedocumentation and application dossiers; - Serve as a point ofcontact with Regulatory Authorities and Regulatory Partners(Distributors, Consultants, etc.); - Support the review process byresponding to reviewers questions and resolving any gaps; - Manageand coordinate post-approval activities, such as design changes,product configuration updates, and license archiving; - Prepareperiodic communications to be submitted to internationalAuthorities to maintain registrations; - Evaluate customercomplaints to determine the reportability of events in accordancewith specific legal and regulatory requirements; - Support thedigitalization of regulatory processes, contributing to thedevelopment of electronic document management systems; - Assess theregulatory impact of design changes, planning and managingnotifications to certification and Regulatory Bodies, and handlingpotential license amendments; - Take part in inspections focused onregulatory matters. WHO WE ARE LOOKING FOR To successfully carryout the required activities, we are looking for candidates with: -Degree in scientific disciplines; - At least 3 years of experiencein regulatory affairs, preferably within the medical deviceindustry. Experience with international registrations is highlydesirable; - Fluency in both English and Italian; - Ability tocollaborate effectively within team; - Strong autonomy in achievinggoals and delivering results; - Enjoy engaging with people fromdiverse cultural backgrounds; - Driven by curiosity and passionateabout new challenges. Technical Skills Required: - Experience indrafting technical files and non-European submissions; - Knowledgeof medical device regulations (MDD, MDR, 21 CFR 803-806-820, 21 CFRCh. I Subpart J, MDSAP, ISO 13485); - Familiarity with ISO 10993,ISO 14971 standards and application principles of technicalstandards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366;- Experience in complaint evaluation and regulatory impactassessment of design changes; - Track record of direct interactionswith Notified Bodies and Competent Authorities; - Knowledge of theeSTAR method for 510(k) submissions (FDA PreMarket Notification); -Experience with cleaning, disinfection, sterilization, andreprocessing of medical devices; - Previous experience with lasertechnology will be considered a plus. Does this sound like theright opportunity for you? Apply now!