Quality & Regulatory Assistant

About Us:

We are Saventic Health, a cutting-edge TechMed startup and a software as a medical device (SaMD) manufacturer. Using artificial intelligence, we assist doctors in diagnosing rare diseases. Our algorithms analyze electronic patient medical records to provide valuable insights for rare disease diagnosis. We have a global presence with offices in Brazil, Germany, Canada, and Poland.

If you’re passionate about quality and regulatory affairs, and want to grow in this field while contributing to cutting-edge technology in healthcare, we’d love to hear from you!

Responsibilities:

• Support in creating process and product documentation to meet standards such as ISO 13485, ISO 27001, MDR, and EN 62304.
• Assist in translating documentation into English.
• Aid in registering products in new markets as part of our company's global expansion.

Requirements:

• No prior experience in quality or regulatory affairs is required, but a strong willingness to develop in this area.
• Currently pursuing higher education (fields such as law, biomedical engineering, or related medical fields are a plus).
• Proficiency in English at a B2 level; knowledge of an additional foreign language is a plus.
• Excellent self-organization, independence, and ability to meet deadlines.
• Strong desire to learn and improve.
• Availability for at least 30 hours per week.
• Remote work (fully)

Join us at Saventic Health and be part of a team that’s transforming healthcare for patients with rare diseases using artificial intelligence!