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 documentation and foster a culture of Compliance by Design.
• Act as the primary point of contact for external audits and stringent technical assessments from pharmaceutical partners.

Requirements

• 510 years in RA/QA specifically focused on Software as a Medical Device (SaMD).
• Deep familiarity with FDA 510(k) EU MDR ISO 13485 ISO 14971 and 21 CFR Part 11. Experience with ISO 27001 IEC 62304 and GDPR is a significant plus.
• You understand the nuances of Clinical Trials and GCP/GxP standards.
• You dont just find problems; you find compliant solutions and you can translate regulatory speak into actionable requirements for the team.
• Fluent in English (German is a bonus). You are comfortable defending our processes to high-level stakeholders at Top-20 Pharma companies.

Benefits

• ki:elements offers a four-day workweek (100% 32 hours; Mo-Th)
• Remote or at our offices in Berlin & Saarbrücken.
• Be part of a pioneering company at the forefront of healthcare innovation.
• Work with a talented and passionate team dedicated to making a difference.
• 73.000 - 92.000 in full time (100%); part-time equivalent.

If our profiles match we would be delighted to hear from you.

Key Skills
Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Employment Type : Employee
Experience: years
Vacancy: 1
Yearly Salary Salary: 73000 - 92000