Regulatory Affairs Specialist Ne

Regulatory Affairs Specialist
Ne
Liguria, Ne

Alchimia 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. 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. To expand our team, we are looking for a Regulatory Affairs Specialist. Main activities: Manage and support the international registration of products by updating and/or preparing the necessary documentation, sending appropriate communications to competent authorities. Support the definition of regulatory requirements for the submission of technical files and the selection of regulatory strategies, collaborating with other departments. Assess the impact of regulatory requirements on products in accordance with changes related to products and processes. Prepare and/or update technical files for products in accordance with regulatory and normative requirements. Maintain the international registration database up-to-date. Prepare and update labeling specifications, IFU, and product labels, risk analysis, post-market documentation (PMS, PMCFP, PMCFR, PSUR, CEP, CER). Keep product and company codes updated according to EUDAMED and other foreign databases, where applicable. Manage reportable events to authorities, performing risk assessments and related communications via FSN, FSCA. Review DHF documentation, collaborating with R&D, QC, and QA departments. Perform gap analysis against new standards and regulations for various technical areas of the device, working with impacted departments for their implementation. Support inspections by Notified Bodies/Competent Authorities regarding product technical documentation. Verify and maintain updated safety data sheets for medical devices. Requirements and Experience: Degree in a scientific field, preferably Biomedical Engineering, Biology, Chemistry and Pharmaceutical Technologies, Pharmacy, Chemical Engineering, Industrial Chemistry, Biotechnology. Preferred experience in the role or similar roles, primarily in the biomedical sector, alternatively in the chemical/chemical-pharmaceutical sector or related fields. Knowledge of standards: ISO 13485, ISO 14971, 93/42/EEC, MDR 2017/745, CFR 21 part 820, CFR 21 part 211, ISO 10993. Excellent command of the English language. The ideal candidate will have the following qualities: Strong analytical and problem-solving skills, with attention to detail. Ability to work independently as well as in a team environment. Excellent communication skills, both written and verbal. Strong organizational skills and ability to manage multiple tasks and meet deadlines effectively. Proactive and positive attitude, with a drive for continuous learning and improvement. Willingness to think outside the box and come up with innovative and creative solutions to challenges. Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges. What we offer: A dynamic and innovative working environment. Opportunities for professional development and growth. A supportive and collaborative team culture. A competitive compensation package commensurate with experience and qualifications. This job posting is open to candidates of all genders, in compliance with applicable laws (L. 903/77 and L. 125/91). Seniority level Associate Employment type Full-time Job function Other Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing J-18808-Ljbffr