Responsibilities
* 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.
Qualifications
* Bachelor degree
* Min 4 years of experience in Regulatory Affairs in the medical device
* Proven experience with global submissions, preferably including FDA,
* Excellent communication and problem-solving skills.
* Fluent in English (written and spoken).