PpAlchimia 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. /p pSince 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. /p pTo support our continuous growth and regulatory strategy, we are looking for a Regulatory Affairs Specialist with strong expertise in MDR and technical documentation preparation. /p h3Main Responsibilities /h3 ul liPrepare and maintain the Technical Documentation (TD) and Design Dossiers in compliance with EU MDR 2017 / 745, especially for Class III, IIa and IIb devices. /li liActively support certification processes with Notified Bodies, managing non-conformities, deficiencies, and corrective / preventive actions (CAPA). /li liCollaborate with internal teams (RD, QA, QC) for the creation, review, and continuous improvement of regulatory documentation. /li liEvaluate regulatory impact of product and process changes, according to MDR art.120, ensuring timely updates of the documentation. /li liConduct regulatory gap analyses against evolving MDR and applicable ISO standards. /li liPrepare and maintain documents including, risk management documentation, PMS, PMCFP, PMCFR, PSUR, CEP, CER. /li liSupport and participate in audits and inspections by Notified Bodies and Competent Authorities. /li liMonitor changes in EU and international regulations and assess their impact on the company’s portfolio conducting gap assessment. /li liAssist in drafting and reviewing Instructions for Use (IFU), labeling, and safety data sheets. /li /ul h3Requirements Experience /h3 ul liDegree in scientific discipline (e.g., Biomedical Engineering, Pharmacy, Biology, Chemistry, Biotechnology, Chemical). /li liMinimum 2–3 years of experience in Regulatory Affairs within the medical device sector, ideally focused on MDR regulation. /li liSolid knowledge of: ul liMDR 2017 / 745 /li liISO 13485, ISO 14971, ISO 10993 /li /ul /li liPrevious experience with Notified Bodies, technical file submissions, and responses to non-conformities or audit findings. /li liStrong English skills (written and verbal) – essential for documentation and communication with regulatory bodies. /li /ul h3Ideal Candidate Profile /h3 ul liStrong problem‑solving and critical thinking skills. /li liHigh attention to detail and structured approach to documentation. /li liProactive attitude and a passion for regulatory compliance. /li liComfortable working autonomously as well as within cross‑functional teams. /li liAbility to handle pressure and manage multiple priorities effectively. /li liCurious, resourceful, and constantly updated on regulatory trends and best practices. /li /ul h3What We Offer /h3 ul liA dynamic, innovative, and growing work environment. /li liDirect involvement in key regulatory projects and strategic certifications. /li liOpportunities for professional growth and regulatory specialization. /li liHybrid working model, meal vouchers, and welfare benefits. /li liA collaborative team with a strong technical and scientific backbone. /li /ul pIf you are passionate about medical device regulation and want to make a real impact in bringing safe, effective, and compliant products to market, we’d love to hear from you. /p h3Apply now and become part of Alchimia’s regulatory team. /h3 pThis job posting is open to candidates of all genders, in compliance with applicable laws (L. 903 / 77 and L. 125 / 91). /p /p #J-18808-Ljbffr