Advanced Regulatory Affairs Specialist
2 giorni fa
Overview Advanced 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 continent. Responsibilities Collaborate on the evaluation of regulatory requirements, preparation, planning, submission, archiving and maintenance of product registrations in the European region and MENA countries. Work with local regulatory partners, legal manufacturers/production sites, and other functions to gather necessary information and documents. Verify the relevance of information to prepare the registration file. Provide documentary support for registration preparations: FSC, statement letters, formatting of documents. Review labelling to ensure compliance with regional and national requirements. Analyze/assess new local regulations related to product registrations, especially in the MEA region, and participate in regulatory watch. Support regulatory requests received from the field (e.g., customers, customs). Participate and contribute to the implementation of global or regional regulatory tools. Represent the Regulatory function and provide regulatory assessments/inputs in cross‑functional projects. Participate in economic operators’ verification activities. Qualifications Bachelor's Degree of Science or Engineering with first experience in Regulatory Affairs positions in a similarly regulated medical industry. Knowledge of medical device regulatory framework. Fluent in English (read, spoken, written). At least 5 years of experience in Regulatory Affairs positions in a similarly regulated medical industry (preferred). Experience in medical device registration file preparation (preferred). Knowledge of Regulatory Information Management Systems (preferred). Very good organizational, administrative and writing skills. Good interpersonal, intercultural and communication skills. Autonomy and capacity to work in remote management. Benefits Bonus plan – percentage depends on position within the organization. Working from home flexibility. Referral bonus and access to ResMed’s preferred shareholding programme. Internal career opportunities within an international, fast‑paced and rapidly growing company. Apply If this sounds like the workplace for you, apply now #J-18808-Ljbffr
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Advanced Regulatory Affairs Specialist
4 giorni fa
WorkFromHome, Italia Resmed A tempo pienoAdvanced Regulatory Affairs Specialist Join to apply for the Advanced Regulatory Affairs Specialist role at ResMed, located in Italy, GB, or Sweden. Overview As part of the EMEA Regulatory Affairs team, you will participate in all regulatory activities related to the import and distribution of ResMed products in the EMEA region, from product registrations to...
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Advanced Regulatory Affairs Specialist
2 giorni fa
WorkFromHome, Italia Resmed A tempo pienoAdvanced Regulatory Affairs Specialist Join to apply for the Advanced Regulatory Affairs Specialist role at ResMed, located in Italy, GB, or Sweden. Overview As part of the EMEA Regulatory Affairs team, you will participate in all regulatory activities related to the import and distribution of ResMed products in the EMEA region, from product registrations to...
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Advanced Regulatory Affairs Specialist
7 giorni fa
WorkFromHome, Italia ResMed Inc A tempo pienoAdvanced Regulatory Affairs Specialist page is loaded## Advanced Regulatory Affairs Specialistlocations: Vimercate, Italy: Didcot, United Kingdom: Kista, Swedentime type: Full timeposted on: Posted Todayjob requisition id: JR\_ **We are looking for our future Advanced Regulatory Affairs Specialist to join our Regulatory team in Italy, GB or Sweden.****Let's...
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Advanced Regulatory Affairs Specialist
2 giorni fa
WorkFromHome, Italia ResMed Inc A tempo pienoOverview Advanced 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...
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WorkFromHome, Italia Resmed A tempo pienoA leading medical technology company is seeking an Advanced Regulatory Affairs Specialist located in Italy. The role involves evaluating regulatory requirements, preparing product registrations for the EMEA region, and ensuring compliance with regional regulations. The ideal candidate should hold a Bachelor's degree in Science or Engineering, have early...
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EMEA Regulatory Affairs Lead
2 giorni fa
WorkFromHome, Italia ResMed Inc A tempo pienoA leading medical technology company is seeking an Advanced Regulatory Affairs Specialist in Rome, Italy. You will be responsible for regulatory activities related to product registrations and compliance across EMEA. The ideal candidate has a Bachelor’s degree in Science or Engineering, at least 5 years of experience in regulatory affairs, and excellent...
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EMEA Regulatory Affairs Specialist — Remote
7 giorni fa
WorkFromHome, Italia ResMed Inc A tempo pienoA leading global healthcare company is seeking an Advanced Regulatory Affairs Specialist in Vimercate, Italy. In this role, you will participate in regulatory activities tied to the import and distribution of medical devices across the EMEA region. The ideal candidate has a Bachelor's Degree in Science or Engineering and at least 5 years of relevant...
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EMEA Regulatory Affairs Specialist — Remote
7 giorni fa
WorkFromHome, Italia ResMed Inc A tempo pienoA global healthcare technology firm in Italy is looking for an Advanced Regulatory Affairs Specialist to join their team. You will participate in all regulatory activities related to the import and distribution of medical devices within the EMEA region, ensuring compliance with regulations. The role requires a Bachelor's degree and experience in the medical...
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REGULATORY AFFAIRS SPECIALIST
3 settimane fa
WorkFromHome, Italia Ecupharma Srl A tempo pienoPharma Point, per conto di Ecupharma, azienda farmaceutica con un solido portafoglio di prodotti nelle aree terapeutiche specialistiche del SNC, urologica e cardiovascolare, è alla ricerca di un / a : Regulatory Affairs Specialist. La figura sarà inserita nel team di Regulatory Affairs e risponderà direttamente al Head of RA. Responsabilità Mantenimento...
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REGULATORY AFFAIRS SPECIALIST
2 settimane fa
WorkFromHome, Italia Ecupharma Srl A tempo pienoPharma Point, per conto di Ecupharma, azienda farmaceutica con un solido portafoglio di prodotti nelle aree terapeutiche specialistiche del SNC, urologica e cardiovascolare, è alla ricerca di un / a : Regulatory Affairs Specialist. La figura sarà inserita nel team di Regulatory Affairs e risponderà direttamente al Head of RA. Responsabilità Mantenimento...
