Regulatory Affairs Expert (m/f/d)

Location: Berlin

Working hours: Full-time

Start date: As soon as possible

About us:

At URIKON, we develop innovative solutions for kidney diagnostics. With our patented technology, we are revolutionizing the stabilization of urine cells to enable new, scalable diagnostic methods.

As a growing company, we are looking for a dedicated regulatory affairs expert (m/f/d) to support us with CE-IVDR certification and other regulatory requirements.

Your responsibilities:

• Development and implementation of the regulatory strategy for CE-IVDR certification.
• Creation and maintenance of technical documentation.
• Support in the submission and approval of the product in Europe and the USA (FDA approval).
• Collaboration with external testing laboratories, notified bodies, and regulatory consultants.
• Ensuring compliance with legal requirements and standards (ISO 13485, IVDR).
• Monitoring regulatory changes and their implementation in the company.

Your profile:

• Completed studies in natural sciences, medicine, engineering, or a related field.
• At least 3 years of experience in the field of regulatory affairs, ideally with a focus on medical devices or in-vitro diagnostics.
• In-depth knowledge of CE-IVDR and ideally of FDA regulations.
• Experience in working with notified bodies and in the preparation of technical documentation.
• Structured, detail-oriented way of working and strong communication skills.
• German and English language skills, written and spoken.

What we offer:

• The opportunity to work on a highly innovative project with a great social impact.
• A key role in a dynamic and interdisciplinary team.
• Flat hierarchies and creative freedom for your own ideas.
• Attractive remuneration and development opportunities in a growing company.

Application:

Please send your complete application documents (curriculum vitae, cover letter, relevant certificates) by e-mail to simon@urikon.de. We look forward to getting to know you!