Regulatory Affairs Associate – Medical Device Spain

What to Expect

• 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.

Requirements

• Bachelor degree


• Min 4 years of experience in Regulatory Affairs in the medical device


• Proven experience with global su...