Apoie o programa de privacidade e proteção de dados, contribuindo para inventários, avaliações de risco, conformidade com a LGPD, atendimento a titulares e organização de evidências e indicadores.
Regulatory Affairs Specialist I
📜 Description
- Assist with preparing regulatory submissions, including 510(k), CE Mark, UKCA, IDE, and clinical trial submissions.
- Track multiple regulatory projects and maintain submission and approval documentation according to internal procedures.
- Support in-country regulatory personnel with global clearances and approvals.
- Research competitor approvals and new or updated regulations and guidance.
- Review product labeling, including Instructions for Use and product labels.
- Support regulatory change assessments and departmental Quality System activities.
🛠️ Requirements
- Bachelor's degree in a relevant discipline or equivalent education and demonstrated experience.
- Medical device regulatory affairs experience preferred.
- Ability to apply technical standards, principles, theories, concepts, and techniques.
- Excellent written, oral, and interpersonal communication skills.
- Proficiency with Word, Excel, PowerPoint, and other computer tools.
✨ Benefits
- A collaborative teamwork environment where learning is constant, and performance is rewarded.
Full job description
• Assist in the tracking of multiple projects concurrently
• Ensure that submission/approval documentation is maintained per internal procedures
• Support in-country RA personnel to facilitate global clearance/approvals.
• Research and obtain information on Regulatory Intelligence such as competitor product information and approvals, new or updated regulations/guidance, as directed.
• Support labeling reviews (e.g., Instructions for Use and product labels).
• Train in existing systems, Work Instructions, and SOPs as needed to support departmental functions and the Quality System.
• Understand Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements
• Support Regulatory change assessment for product changes.
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