Lavori attuali relativi a Regulatory Affairs Specialist - Roma - Nordberg Medical
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REGULATORY AFFAIRS SPECIALIST
5 giorni fa
Roma, Italia Openjobmetis S.p.A. A tempo pienoRegulatory Affairs Specialist – Openjobmetis S.p.A. Openjobmetis S.p.A., Agenzia per il Lavoro, ricerca per azienda cliente operante nella produzione chimico / cosmetico, 1 Regulatory Affairs Specialist. Nel settore cosmetico, il Regulatory Affairs garantisce che i prodotti siano conformi alle normative vigenti, gestendo la documentazione, valutando la...
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REGULATORY AFFAIRS SPECIALIST
5 giorni fa
Roma, Italia Openjobmetis S.p.A. A tempo pienoRegulatory Affairs Specialist – Openjobmetis S.p.A. Openjobmetis S.p.A., Agenzia per il Lavoro, ricerca per azienda cliente operante nella produzione chimico / cosmetico, 1 Regulatory Affairs Specialist. Nel settore cosmetico, il Regulatory Affairs garantisce che i prodotti siano conformi alle normative vigenti, gestendo la documentazione, valutando la...
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REGULATORY AFFAIRS SPECIALIST
6 giorni fa
giuliano di roma, Italia Openjobmetis S.p.A. A tempo pienoRegulatory Affairs Specialist – Openjobmetis S.p.A.Openjobmetis S.p.A., Agenzia per il Lavoro, ricerca per azienda cliente operante nella produzione chimico / cosmetico, 1 Regulatory Affairs Specialist.Nel settore cosmetico, il Regulatory Affairs garantisce che i prodotti siano conformi alle normative vigenti, gestendo la documentazione, valutando la...
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REGULATORY AFFAIRS SPECIALIST
5 giorni fa
giuliano di roma, Italia Openjobmetis S.p.A. A tempo pienoRegulatory Affairs Specialist – Openjobmetis S.p.A.Openjobmetis S.p.A., Agenzia per il Lavoro, ricerca per azienda cliente operante nella produzione chimico / cosmetico, 1 Regulatory Affairs Specialist.Nel settore cosmetico, il Regulatory Affairs garantisce che i prodotti siano conformi alle normative vigenti, gestendo la documentazione, valutando la...
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Cosmetics Regulatory Affairs Specialist
5 giorni fa
Roma, Italia Openjobmetis S.p.A. A tempo pienoUn'agenzia per il lavoro sta cercando un Regulatory Affairs Specialist da inserire in un'azienda operante nel settore chimico/cosmetico. Il candidato sarà responsabile della preparazione e gestione della documentazione normativa e della valutazione della sicurezza dei prodotti. È richiesta una formazione specifica in Regulatory Affairs e una buona...
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Regulatory Affairs Specialist
1 settimana fa
Roma, Italia Angelini Pharma A tempo pienoRequisition ID: 6227- Location: Roma, IT- Company: ANGELINI PHARMA SPA- Professional area: Medical, R&D- Job Description: - _We have an opportunity for a _**_Regulatory Affairs Specialist._** **_Main activities:_** - _ Definition and development of regulatory strategies, supporting the Regulatory Affairs Director and in line with the Company’s needs._ -...
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Cosmetics Regulatory Affairs Specialist
5 giorni fa
giuliano di roma, Italia Openjobmetis S.p.A. A tempo pienoUn'agenzia per il lavoro sta cercando un Regulatory Affairs Specialist da inserire in un'azienda operante nel settore chimico/cosmetico. Il candidato sarà responsabile della preparazione e gestione della documentazione normativa e della valutazione della sicurezza dei prodotti. È richiesta una formazione specifica in Regulatory Affairs e una buona...
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EMEA Regulatory Affairs Specialist — Remote
5 giorni fa
roma, Italia Partner.Co A tempo pienoA global health and wellness company is seeking a Regulatory Affairs Specialist (EMEA) to ensure compliance with EU regulations. The role involves preparing regulatory documentation, coordinating submissions, and collaborating with cross-functional teams. The ideal candidate will have a Bachelor’s degree in a relevant field and 3 to 5 years of experience...
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Regulatory Affairs Specialist
2 settimane fa
Roma, Italia TransPerfect A tempo pienoA medical device company in Rome is seeking a Regulatory Affairs Specialist to support CE marking activities and ensure regulatory compliance for medical devices. The ideal candidate will have 3-5 years of experience in Regulatory Affairs, strong knowledge of CE marking regulations, and excellent communication skills in English. This role involves...
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Advanced Regulatory Affairs Specialist
3 settimane fa
giuliano di roma, Italia ResMed Inc A tempo pienoOverviewAdvanced Regulatory Affairs Specialist – responsible for regulatory activities related to the import and distribution of ResMed products in the EMEA region, from product registrations to post‑market activities. The role involves collaborating with local regulatory partners, legal manufacturers and other functions to ensure compliance across the...
Regulatory Affairs Specialist
3 ore fa
Regulatory Affairs Specialist -Medical DevicesJoin to apply for the Regulatory Affairs Specialist -Medical Devices role at Nordberg MedicalRegulatory Affairs Specialist -Medical DevicesJoin to apply for the Regulatory Affairs Specialist -Medical Devices role at Nordberg MedicalGet AI-powered advice on this job and more exclusive features.The Regulatory Affairs Specialist is responsible for preparing, submitting, and maintaining regulatory documentation to support global approvals of high-risk or implantable medical devices. This role ensures compliance with U.S. FDA regulations, EU MDR 2017/745, and other international requirements, supporting product lifecycle management from development through post-market surveillance.Department: Regulatory AffairsReports To: Senior Regulatory Affairs ManagerKey ResponsibilitiesPrepare and submit regulatory documents such as IDEs, PMAs, PMA Supplements, Technical Documentation (per EU MDR), and global registrations (e.g., Canada, Japan, China, Australia).Ensure labeling, Instructions for Use (IFUs), and promotional materials meet regulatory requirements for Class III devices.Lead or support regulatory strategy development for new product introductions, design changes, and sustaining products.Maintain compliance with regulatory standards including FDA 21 CFR Parts 807, 812, 814, and EU MDR Annexes I–III, IX, X.Support the maintenance of Clinical Evaluation Reports (CERs), Risk Management documentation (ISO 14971), and Post-Market Surveillance (PMS) activities.Collaborate with cross-functional teams (R&D, Clinical, Quality, Marketing) to ensure regulatory requirements are met throughout the product lifecycle.Participate in internal audits, FDA inspections, and Notified Body assessments as the Regulatory SME.Monitor and communicate changes in global regulations and assess the impact on existing products and documentation.Maintain regulatory records, files, and tracking systems in accordance with company procedures and quality systems (ISO 13485, QSR).Skills and requirementsQualificationsRequired:Bachelor's degree in Regulatory Affairs, Biology, Pharmaceutical, Life Sciences, or related field.2+ years of regulatory affairs experience in the medical device industry, with at least 2 years supporting Class III devices.Strong working knowledge of U.S. FDA regulatory pathways (e.g., PMA, IDE) and EU MDR Technical Documentation requirements.Experience preparing regulatory submissions and responding to regulatory authority queries.Familiarity with ISO 13485, ISO 14971, and applicable international regulations (e.g., TGA, PMDA, NMPA).Strong project management, organizational, and communication skills.PreferredExperience with implantable devices.Experience with software used in documentation and submission preparation (e.g., regulatory databases).PersonalityIndependent: You are independent in organizing your daily tasks, able to manage your work in a remote setting.Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance.Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholdersSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionLegalReferrals increase your chances of interviewing at Nordberg Medical by 2xGet notified about new Regulatory Affairs Specialist jobs in Italy.Senior Regulatory Affairs Specialist - EU- RemoteSenior Regulatory Affairs Specialist - EU- RemoteRegulatory Affairs Manager Medical DevicesLocal Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) - Italian, French & EnglishQuality Assurance Specialist - Gestione FornitoriGlobal Quality and Accreditation Artificial Intelligence Technical & Regulatory ReviewerBolzano, Trentino-Alto Adige, Italy 3 weeks agoRimini, Emilia-Romagna, Italy 3 weeks agoProvince of Medio Campidano, Sardinia, Italy 3 weeks agoModena, Emilia-Romagna, Italy 3 weeks agoQuality Assurance Software Specialist (Rif. 2025-97)Trento, Trentino-Alto Adige, Italy 3 weeks agoWe're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
