Job Title

Company Description Royal Surgicare Pvt. Ltd. is a trusted manufacturer and exporter of quality medical consumables, based in Santej(Gujarat, India). We offer a wide range of products for Infusion Therapy, Transfusion Therapy, Gastroenterology, Urology, Anesthesia, and General surgery. Our facility operates under ISO 13485: 2016 standards to ensure consistent product quality. We are committed to delivering reliable and precise medical solutions. Role Description Oversee all Quality Assurance and Quality Control activities to ensure product safety, quality, and compliance. Ensure adherence to ISO 13485, EUMDR and applicable regulatory requirements. Review and approve quality documents, SOPs, and batch records. Maintain and update technical documentation and declarations of conformity. Ensure product conformity before release and manage regulatory submissions/registrations. Monitor post-market surveillance, vigilance, and CAPA activities. Lead internal audits, risk management, and training programs. Liaise with regulatory authorities, consultants, and Notified Bodies. Ensure labeling, traceability, and documentation compliance for all medical devices. Support continuous improvement and readiness for inspections and audits. Qualifications Quality Control and Quality Assurance skills Quality Management and Analytical Skills Laboratory Skills Excellent written and verbal communication skills Strong interpersonal and leadership abilities Familiarity with ISO and EUMDR standards