Senior Quality & Regulatory Affairs Manager

ki:elements pioneers speech-based biomarkers as tools for clinical research. We are looking for a Quality & Regulatory Lead to bridge the gap between our agile company and the rigorous demands of global clinical trials.

Regulatory excellence is central to our operations. Reporting directly to the CEO, you will own our compliance roadmap, shape our regulatory strategy, refine our QMS, and ensure our technology meets the highest standards for both FDA/EMA and our global pharma partners.

Tasks

• Lead the roadmap development and management for key certifications, specifically FDA 510(k) clearance and EU MDR.


• Ensure our technology aligns with clinical trial requirements, including 21 CFR Part 11 and GCP/GxP standards.


• Oversee our QMS (ISO 13485 / ISO 27001).


• Manage and mentor the existing RA/QA staff. You will set priorities, review technical docu...