Advanced Regulatory Affairs Specialist
1 giorno 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.ResponsibilitiesCollaborate 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.QualificationsBachelor'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.BenefitsBonus 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.ApplyIf this sounds like the workplace for you, apply now#J-*****-Ljbffr
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Advanced Regulatory Affairs Specialist
1 giorno fa
Lazio, 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...
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