Advanced Regulatory Affairs Specialist
1 giorno fa
Advanced 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 the follow‑up of product changes and post‑market activities. You will work on European processes with other functions to ensure overall compliance, liaise at the interface between the legal manufacturer and country partners for proper coordination, and contribute to the implementation of the new European medical‑device regulation. Key Responsibilities Evaluate regulatory requirements, prepare, plan, submit, archive, and maintain product registrations in the European region & MENA countries to achieve timely approvals in line with commercial distribution and regulatory plans. Collaborate with local regulatory partners, legal manufacturers/production sites, and other on‑site functions to obtain information and documents needed for registrations. Verify the relevance of information to prepare the registration file. Provide documentary support for registrations: FSC, statement letters, document formatting. Review labeling to ensure compliance with regional and national requirements. Analyze and assess new local regulations related to product registrations, especially in the MEA region, and participate in regulatory watch. Support regulatory requests from the field (e.g., customers, customs). Participate and contribute to the implementation of global or regional regulatory tools. Contribute to cross‑functional projects; represent the Regulatory function and provide regulatory assessments/inputs. Participate in economic operators’ verification activities. Qualifications and Experience Required: Bachelor’s Degree in Science or Engineering with early experience in Regulatory Affairs within a similarly regulated medical industry. Knowledge of the medical device regulatory framework. Fluent in English (reading, speaking, writing). Preferred: At least 5 years of experience in Regulatory Affairs within a similar medical industry. Experience preparing medical device registration files. Knowledge of Regulatory Information Management Systems. Very good organizational, administrative, and writing skills. Strong interpersonal, intercultural, and communication skills. Ability to work autonomously in a remote‑management environment. Benefits Bonus plan based on position within the organization. Flexibility to work from home. Referral bonus and access to ResMed’s preferred shareholding program. Internal career opportunities in an internationally growing company. What’s Next? Joining us means more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive, and inspiring. Our culture is driven by excellence, diversity, and inclusivity, encouraging individual expression and innovative ideas. If this sounds like the right place for you, apply now Seniority level: Mid‑Senior level | Employment type: Full‑time | Job function: Legal #J-18808-Ljbffr
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Advanced Regulatory Affairs Specialist
3 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
1 giorno 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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Advanced Regulatory Affairs Specialist
1 giorno 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
1 giorno 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...
