Regulatory Affairs Associate

Alchimiais one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With our expertise in chemistry, microbiology, and pharmacology, we have adopted a simple rule: we design each medical device as if it were intended for ourselves. Since our foundation in 1993, all our products have been developed in close collaboration with opinion leaders and the scientific community before being released to the market. This approach allows us to offer safe, effective, and reliable solutions that improve the daily work of healthcare professionals and the quality of life of their patients. Our ongoing commitment to research makes us a trusted partner, providing continuous training and up-to-date scientific information to our distributors and users. Thanks to our dedicated team, Alchimia now operates through a network of over 60 independent distributors worldwide, offering fast and reliable local support to customers everywhere.Position OverviewTo strengthen our team, we are looking for aRegulatory Affairs Associateto support regulatory compliance and product registrations worldwide. The ideal candidate will contribute to maintaining high-quality regulatory documentation and ensuring that Alchimia’s medical devices meet all applicable international standards and regulations.Main ResponsibilitiesManageandsupportinternationalproduct registrationsby preparing and updating required documentation and communicating with competent authorities. Supportthedefinition of regulatory requirementsandstrategiesfor technical file submissions in collaboration with cross-functional teams. Assessthe impact of product andprocesschanges on regulatory compliance. Prepareandupdate product technical filesin accordance with regulatory and normative requirements. Maintain up-to-date international registration databases. Prepareandrevise labeling specifications, IFUs, product labels, and post-market documentation (PMS, PMCFP, PMCFR, PSUR, CEP, CER). Keepproduct and company data aligned with EUDAMED and other relevant international databases. Managereportable events,performrisk assessments, andcommunicatewith authorities (FSN, FSCA). Review Design History File(DHF) documentation in collaboration with R&D, QC, and QA departments. Performgap analyses against new standards and regulations, coordinating implementation with relevant departments. Supportinspections by Notified Bodies and Competent Authorities related to product technical documentation. Verifyandmaintainupdated safety data sheets for medical devices.Qualifications and ExperienceDegreeinscientific discipline(preferably Biomedical Engineering, Biology, Chemistry and Pharmaceutical Technologies, Pharmacy, Chemical Engineering, Industrial Chemistry, or Biotechnology). Prior experience(minimum 1 year preferred)in Regulatory Affairsor related roles within the biomedical, chemical, or pharmaceutical sectors. Knowledge of key standards and regulations:ISO 13485, ISO 14971, ISO 10993, 93/42/EEC, MDR 2017/745, CFR 21 Part 820, CFR 21 Part 211. Excellent command ofEnglish, both written and spoken.Key CompetenciesStrong analytical andproblem-solving skills, with great attention to detail. Abilityto work both independently and collaboratively in a team environment. Excellentwrittenandverbal communication skills. Strong organizational skills, with the ability to manage multiple tasks and meet deadlines. Proactive,positiveattitude with a drive for continuous learning and improvement. Creative thinker, open to innovation and new approaches. Comfortable working in adynamic environmentand adaptable to changing priorities.What We OfferA dynamic and innovative working environment. Opportunities for professional development and career growth. A supportive and collaborative team culture. A competitive benefits package, including meal vouchers, welfare programs, and smart working options.If you are a highly motivated professional with a passion for regulatory affairs and medical device innovation, we encourage you to apply and join our growing team This job posting is open to candidates of all genders, in compliance with applicable laws (L. 903/77 and L. 125/91).