PstrongAlchimia /strong is one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With our expertise in the fields of chemistry, microbiology, and pharmacology, at Alchimia we have adopted this rule: we design each medical device as if it were intended for ourselves. /pp Since our foundation in 1993, all our products have been developed in collaboration with opinion leaders and the scientific community before being released to the market. This allows us to offer safe, useful, and effective solutions to improve the daily operations of medical staff and the quality of life of their patients. Our commitment to research makes us a reliable partner, able to provide ongoing training and updated scientific information to our distributors and product users. Thanks to the Alchimia team, we now have a network of over 60 independent distributors across Europe and the world, capable of providing fast local service to all our customers. /ppbr/ppTo support our continuous growth and regulatory strategy, we are looking for astrong Regulatory Affairs Specialist /strongwith strong expertise in MDR and technical documentation preparation. /ppbr/ppstrongMain Responsibilities /strong /ppbr/pullistrongPrepare and maintain the Technical Documentation (TD) and Design Dossiers /strong in compliance with strongEU MDR 2017/745 /strong, especially for Class III, IIa and IIb devices. /liliActively support strongcertification processes with Notified Bodies /strong, managing strongnon-conformities, deficiencies, and corrective/preventive actions (CAPA). /strong /liliCollaborate with internal teams (RD, QA, QC) for the strongcreation, review, and continuous improvement of regulatory documentation /strong. /liliEvaluate strongregulatory impact /strong of strongproduct and process changes /strong, according to MDR art.120, ensuring timely updates of the documentation. /liliConduct strongregulatory gap analyses /strong against evolving MDR and applicable ISO standards. /liliPrepare and maintain documents including, strongrisk management documentation, PMS, PMCFP, PMCFR, PSUR, CEP, CER /strong. /liliSupport and participate in strongaudits and inspections by Notified Bodies and Competent Authorities /strong. /liliMonitor changes in EU and international regulations and assess their impact on the company’s portfolio conducting gap assessment. /liliAssist in drafting and reviewing strongInstructions for Use (IFU), labeling, and safety data sheets /strong. /li /ulpbr/ppstrongRequirements Experience /strong /ppbr/pulliDegree in scientific discipline (e.g., strongBiomedical Engineering /strong, strongPharmacy /strong, strongBiology /strong, strongChemistry /strong, strongBiotechnology, Chemical) /strong. /lilistrongMinimum 2–3 years of experience in Regulatory Affairs /strong within the strongmedical device sector /strong, ideally focused on strongMDR regulation /strong. /liliSolid knowledge of: /lilistrongMDR 2017/745 /strong /lilistrongISO 13485 /strong, strongISO 14971 /strong, strongISO 10993 /strong /liliPrevious experience with strongNotified Bodies /strong, technical file submissions, and responses to strongnon-conformities /strong or strongaudit findings /strong. /lilistrongStrong English skills /strong (written and verbal) – essential for documentation and communication with regulatory bodies. /li /ulpbr/ppstrongIdeal Candidate Profile /strong /ppbr/pulliStrong strongproblem-solving /strong and critical thinking skills. /lilistrongHigh attention to detail /strong and structured approach to documentation. /lilistrongProactive /strong attitude and a passion for regulatory compliance. /liliComfortable working autonomously as well as within cross-functional teams. /lilistrongAbility to handle pressure /strong and manage multiple priorities effectively. /lilistrongCurious /strong, resourceful, and constantly updated on regulatory trends and best practices. /li /ulpbr/ppstrongWhat We Offer /strong /ppbr/pulliA dynamic, innovative, and growing work environment. /liliDirect involvement in key regulatory projects and strategic certifications. /liliOpportunities for professional growth and regulatory specialization. /liliHybrid working model, meal vouchers, and welfare benefits. /liliA collaborative team with a strong technical and scientific backbone. /li /ulpbr/ppIf you are passionate about strongmedical device regulation /strong and want to make a real impact in bringing strongsafe, effective, and compliant /strong products to market, we’d love to hear from you. /ppstrongApply now and become part of Alchimia’s regulatory team. /strong /ppThis job posting is open to candidates of all genders, in compliance with applicable laws (L. 903/77 and L. 125/91). /p