What to Expect
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Conduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.
Manage annual registrations, license renewals, and ongoing regulatory notifications.
Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.
Coordinate the collection, review, and consolidation of data for international regulatory registrations.
Collaborate with global Regulatory Affairs partners and cross-functional stakeholders to ensure timely, compliant submissions.
Execute administrative, documentation, and procedural activities supporting the Regulatory Affairs function. xhfqzwm
Requirements
Bachelor degree
Min 4 years of experience in Regulatory Affairs in the medical device
Proven experienc...