Quality Assurance / Regulatory Affairs (QA/RA) Director

• Serve as Person Responsible for Regulatory Compliance (PRRC) under IVDR
• Establish and maintain an ISO 13485 Quality Management System
• Define and implement regulatory strategy for new products and market entry
• Ensure efficient development processes in collaboration with the development team
• Perform internal audits, supplier audits, and manage quality agreements with manufacturing partners
• Lead clinical performance evaluation activities, including planning and oversight of clinical activities and Post-Market Surveillance (PMS)
• Prepare, maintain, and submit technical documentation to regulatory authorities and interaction with Notified Bodies for conformity assessment
• Drive a quality-first culture across the organization through training and leadership

• Minimum 4 years of experience with MDR/IVDR regulations
• Proven track record in Quality Assurance and Regulatory Affairs within the medical device industry
• Strong knowledge of ISO 13485 and quality system implementation
• Experience with clinical evaluation processes and regulatory submissions
• Excellent leadership, communication, and problem-solving skills

Experience with in-vitro diagnostics is an advantage but not required

• A pivotal role in shaping MedicQuant’s compliance and quality strategy
• Opportunity to influence the company’s regulatory roadmap and product development
• Collaboration with external regulatory consultants for specialized expertise
• Dynamic, innovative environment with room for professional growth, in an international setting