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Regulatory Affairs Associate
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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).
