Regulatory Affairs
2 settimane fa
Alchimia is 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. 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 Overview To strengthen our team, we are looking for a Regulatory Affairs Associate to 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. Support the definition of regulatory requirements and strategies for technical file submissions in collaboration with cross‐functional teams. Assess the impact of product and process changes on regulatory compliance. Prepare and update product technical files in accordance with regulatory and normative requirements. Maintain up‐to‐date international registration databases. Keep product and company data aligned with EUDAMED and other relevant international databases. Manage reportable events, perform risk assessments, and communicate with authorities (FSN, FSCA). Verify and maintain updated safety data sheets for medical devices. Qualifications and Experience Degree in scientific discipline (preferably Biomedical Engineering, Biology, Chemistry and Pharmaceutical Technologies, Pharmacy, Chemical Engineering, Industrial Chemistry, or Biotechnology). Prior experience (minimum 1 year preferred) in Regulatory Affairs or related roles within the biomedical, chemical, or pharmaceutical sectors. Excellent command of English, both written and spoken. Creative thinker, open to innovation and new approaches. 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.
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Regulatory Affairs Specialist
1 settimana fa
Padova, Italia Alchimia Srl A tempo pienoRegulatory Affairs Specialist needed to prepare and maintain technical documentation, support certification processes, and ensure regulatory compliance.
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Regulatory Affairs Associate
1 settimana fa
Padova, Italia Alchimia Srl A tempo pienoThe Regulatory Affairs Associate will support product registrations and regulatory compliance.They will manage documentation, communicate with authorities, and ensure medical devices meet international standards.
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Regulatory Affairs Associate
6 giorni fa
Padova, Italia Alchimia Srl A tempo pienoThe Regulatory Affairs Associate will support product registrations worldwide, ensuring compliance with international standards and regulations.
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Regulatory Affairs
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Padova, Italia Stevanato Group A tempo pienoA leading medical device company in Italy is seeking a Regulatory & Scientific Affairs Specialist. The candidate will manage regulatory processes, prepare documentation, and ensure compliance with standards in the healthcare industry. Candidates should have 2-5 years of experience in regulatory affairs or quality assurance in pharmaceuticals or medical...
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Regulatory Affairs
3 settimane fa
Padova, Italia Stevanato Group A tempo pienoA leading medical device company in Italy is seeking a Regulatory & Scientific Affairs Specialist. The candidate will manage regulatory processes, prepare documentation, and ensure compliance with standards in the healthcare industry. Candidates should have 2-5 years of experience in regulatory affairs or quality assurance in pharmaceuticals or medical...
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Addetto Regulatory Affairs Junior
3 giorni fa
Padova, Italia Relizont A tempo pienoADDETTO REGULATORY AFFAIRS JUNIORCategoria:Affari legaliLuogo di lavoro:CONSELVEAzienda Clientedel settore chimico ci ha affidato l'incarico di individuareuna Persona interessata a ricoprire il ruolo diADDETTO REGULATORY AFFAIRS JUNIOR, da assumerea tempo indeterminato.Luogo di lavoro:CONSELVE(PD)Il ruolo diADDETTO REGULATORY AFFAIRS JUNIORprevede :sviluppo...
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Regulatory Affairs Specialist
2 settimane fa
Padova, Italia Alchimia Srl A tempo pienoA leading medical device manufacturer in Padova is seeking a Regulatory Affairs Associate. This role involves managing international product registrations, ensuring compliance with relevant regulations, and maintaining technical documentation. The ideal candidate should have a degree in a scientific discipline and prior experience in Regulatory Affairs....
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Regulatory Affairs Specialist – MedTech Devices
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Padova, Italia Alchimia Srl A tempo pienoA leading medical device manufacturer in Padova is seeking a Regulatory Affairs Associate. This role involves managing international product registrations, ensuring compliance with relevant regulations, and maintaining technical documentation. The ideal candidate should have a degree in a scientific discipline and prior experience in Regulatory Affairs....
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Addetto Regulatory Affairs Junior
3 giorni fa
Padova, Italia Relizont A tempo pienoADDETTO REGULATORY AFFAIRS JUNIOR Categoria: Affari legaliLuogo di lavoro: CONSELVEAzienda Cliente del settore chimico ci ha affidato l'incarico di individuare una Persona interessata a ricoprire il ruolo di ADDETTO REGULATORY AFFAIRS JUNIOR, da assumere a tempo indeterminato.Luogo di lavoro: CONSELVE (PD) Il ruolo di ADDETTO REGULATORY AFFAIRS JUNIOR...
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Regulatory Affairs Officer
1 settimana fa
Padova, Italia Antal International A tempo pienoLa Società - Azienda leader nel settore cosmetico e nutraceutico - Il Ruolo - Stiamo ricercando un/a: **Regulatory Affairs Officer** - Principali attività: - Redazione della documentazione per l’ottenimento ed il mantenimento delle autorizzazioni all’ammissione in commercio dei prodotti; - Gestione delle pratiche di registrazione presso le Autorità...
