Head of qa/ra

Position Summary: Head of Quality Assurance (QA) / Regulatory Affairs (RA) Prunus Italy SRL , located in Mirandola, Italy, is seeking a strategic and highly experienced Head of Quality Assurance (QA) / Regulatory Affairs (RA) to lead and oversee all quality and regulatory activities across the organization. This individual will be responsible for ensuring compliance with global regulatory requirements, designing and maintaining a robust Quality Management System (QMS), and supporting product development and commercialization strategies. The role is critical to maintaining product integrity, patient safety, and market access worldwide. Prunus Italy SRL is a subsidiary of Prunus Europe AG located in Switzerland. This position includes several responsibilities for the parent company in Switzerland. The position will report directly to the European CEO. Job Description and Tasks: Organization and Management: Manage QA/RA functions, including strategic leadership and operational oversight. Strategic Leadership: Define and lead the overall QA/RA strategy aligned with company goals and global regulatory expectations. Serve as the quality and regulatory representative to executive leadership, regulatory authorities, and external partners. Development and Maintenance of QMS: Develop (from scratch), implement, and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and other standards. Regulatory Compliance: Duties of PRRC according to MDR, ensuring effective execution of quality processes such as CAPA, audits, supplier management, risk management, clinical affairs, and change control. Inspection and Audit Leadership: Provide leadership during inspections and audits by regulatory agencies and notified bodies. Regulatory Strategy: Oversee global regulatory strategies for new product development, submissions, approvals, and lifecycle management. Prepare and submit regulatory dossiers (FDA, EU MDR, etc.). Monitoring Trends: Monitor regulatory trends and assess their impact on products and business. Qualifications & Experience: Bachelor’s or Master’s in Life Sciences, Engineering, Regulatory Science, or related; 7 years in QA/RA, with 5 years in leadership roles, deep knowledge of FDA, EU MDR, ISO 13485, and successful regulatory submissions. Company Profile: Prunus specializes in high-quality disposables and hardware for Critical Care, with products sold in over 70 countries. The company is expanding its European footprint with new subsidiaries in Italy and Switzerland, focusing on innovative Class IIb medical devices to improve patient outcomes. J-18808-Ljbffr

Location: mirandola, IT

Posted Date: 5/10/2025