Functions:
• Understand and interpret EU and US medical device regulatory requirements.
• Develop, prepare, and execute project plans for all phases of the project lifecycle, including quality, risk management and proactive contingency plans, ensuring that issue escalation and resolution is clear
• Draft and prepare general and product technical documentation for CE marking activities and notified body interaction to accomplish product authorization.
• Draft and prepare 510(k) submission and lead process through clearance/approval.
• Review and / or develop analytical and clinical protocols, and device performance evaluation plans and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
• Finalize and review regulatory documents and submissions.
• Provide support in start-ups, management, monitoring and close-out of different research projects.
• Ensure the accuracy and quality standards of the different clinical studies and project documents.
• Provide support managing clinical, regulatory and study-related documents (e.g. informed consent forms, study protocols, reports, SOPs).
Requeriments:
- Bachelor’s degree or equivalent in Health Sciences (Biology, Biochemistry, Medicine, Pharmacy or similar) and Master’s degree specialized on Medical Device.
- Minimum 2 years’ experience in regulatory Affairs in the device industry.
- Working knowledge of FDA Guidance Documents/EU Directives/ISO13485 regulations, device development, and clinical monitoring procedures
- Advanced level of English (B2 or higher).
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