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
