Regulatory Affairs Specialist
6 giorni fa
Advanced Regulatory Affairs Specialist
Join to apply for the Advanced Regulatory Affairs Specialist role at ResMed, located in Italy, GB, or Sweden.
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.
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., 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.
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).
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.
Ability to work autonomously in a remote‐management environment.
Flexibility to work from home.
Mid‐Senior level | Employment type: Full‐time | Job function: Legal
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Advanced Regulatory Affairs Specialist
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Vimercate (MB), 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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Vimercate (MB), 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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vimercate, Italia Resmed A tempo pienoAdvanced Regulatory Affairs SpecialistJoin to apply for the Advanced Regulatory Affairs Specialist role at ResMed, located in Italy, GB, or Sweden.OverviewAs 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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vimercate, Italia Resmed A tempo pienoAdvanced Regulatory Affairs SpecialistJoin to apply for the Advanced Regulatory Affairs Specialist role at ResMed, located in Italy, GB, or Sweden.OverviewAs 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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Vimercate, Italia Resmed A tempo pienoAdvanced Regulatory Affairs SpecialistJoin to apply for the Advanced Regulatory Affairs Specialist role at ResMed, located in Italy, GB, or Sweden.OverviewAs 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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Vimercate, 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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