Regulatory Affairs Medical Devices

Company: ElevenClock Healthcare Pvt. Ltd. Job Summary: ElevenClock Healthcare Pvt. Ltd. is seeking a Regulatory Affairs Executive to manage medical device registrations, regulatory documentation, and compliance for domestic and international markets. Key Responsibilities: Prepare and submit product registration dossiers. Maintain regulatory licenses, certifications, and renewals. Ensure compliance with CDSCO, ISO 13485, CE/MDR, and other applicable regulations. Prepare technical documentation, labels, IFUs, and product files. Coordinate with regulatory authorities, consultants, and internal departments. Support audits and maintain regulatory records. Qualifications: Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field. 1–3 years of experience in Medical Device Regulatory Affairs preferred. Strong knowledge of regulatory documentation and compliance requirements.