Executive ( RA , QA ) ( Level I / II )

Job Description

Executive (RA, QA) ( Level I/ II) Executive (RA, QA) ( Level I/ II) subrat kumar 2025-04-24T12:40:11+05:30 Executive (RA, QA) ( Level I/ II) JC OrthoHeal Private Limited is looking for Executive (RA, QA) ( Level I/ II) to grow our footprints. JOB ID: OHRA250401 Job family Regulatory Affairs Position Title E xecutive (RA, QA) ( Level I/ II) Job Type Full Time Manjuser, Vadodara Nature of Work On-site Company Name JC OrthoHeal Private Limited Updated on 24.04.2025 OrthoHeal is a leading Med-Tech company specializing in orthopedic medical devices. The company focuses on improving post-operative orthopedic recoveries and innovating technologies to enhance patient care. OrthoHeal s flagship product, FlexiOH , is a cutting-edge orthopedic immobilization technology designed for comfort and effectiveness. About the Role: Executive (RA, QA) ( Level I/ II) will work with the regulatory team and Formulate or implement regulatory affairs policies and procedures. Key Responsibilities: Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Develop or compile all the necessary documents required for the regulatory submissions. Maintain the device registration status and ensure timely re-registration. Assist in providing support to the local and international distributors to register devices when required. Collect and analyse data of Legal and Regulatory requirements including mandatory label marking requirements. Assist in training staff in regulatory policies or procedures. Participate in the development or implementation of clinical trial protocols. Supports post market surveillance and vigilance activity when it is required. Maintain and upkeep of all regulatory information, technical file, licenses, and certificates. Draft applicable QMS procedures and formats as per ISO 13485 in the organization. Manage change control activities. Ensure the effectiveness of the quality management system. Set and track quality assurance goals. Documentation and Record keeping. Qualifications: Education : Graduation/ Post Graduate in Science. Skills: Basic computer skills. Able to work in a strict timeline. Strong organizational and persuasive skills. Good verbal and communication skills