Regulatory Documentation Work From Home Part Time Internship

Selected intern's day-to-day responsibilities include:

1. Assisting in the preparation of comprehensive EU MDR technical files in compliance with the European Union Medical Device Regulation (EU MDR).
2. Supporting the creation and organization of FDA submission documents for market approval.
3. Leveraging understanding of major country-specific regulations (such as EU MDR, FDA, and other international regulations) to contribute to accurate and compliant documentation.
4. Participating in identifying and documenting potential gaps in existing documentation and processes to ensure full regulatory compliance.
5. Aiding in meeting the requirements of the Medical Device Single Audit Program (MDSAP) for market access in multiple jurisdictions.
6. Assisting in maintaining and improving Quality Management System (QMS) processes to comply with ISO 13485 and other relevant standards.

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