Regulatory Affairs Specialist
Vor 6 Tagen
Job Summary:
EPM Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with national and international regulatory requirements for medical devices.
Key Responsibilities:
- Regulatory Documentation: Create and update 510(k) regulatory documentation for devices and instruments, including Premarket Notification and Letter to File.
- Predicate Device Selection: Select and justify predicate devices for performance.
- Material Suitability: Verify the suitability of materials for medical devices.
- Labeling Implementation: Ensure correct implementation of labeling for medical devices.
- FDA Compliance: Announce and list products with the FDA, and serve as the primary contact person.
- Documentation Updates: Update documentation for product changes, including argumentation for changes in intended use.
Requirements:
- Education: Bachelor's degree in a relevant field.
- Experience: Over three years of professional experience in the medical device industry.
- Language Skills: Fluent knowledge of English and German (B2 level).
- Technical Skills: Sound knowledge of MS Office applications.
- Work Style: Highly structured and organized work style.
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