Jr RA Executive

Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, new product development, and high-quality production of nephrology and healthcare products. We are looking for motivated and detail-oriented fresh graduates to join our Regulatory Affairs (RA) team. This role offers exposure to medical device regulations, product registrations, technical documentation, and compliance processes.

Requirements

• Assist in preparation and compilation of regulatory dossiers for medical devices.
• Support product registration and licensing activities with regulatory authorities (CDSCO and other global markets).
• Maintain and organize technical documentation, Device Master Files (DMF), and regulatory records.
• Ensure compliance with applicable regulatory standards and guidelines.
• Assist in Labelling review, IFU (Instructions for Use), and artwork compliance checks.
• Support change control documentation and regulatory impact assessments.
• Coordinate with QA, R&D, and production teams for regulatory submissions.
• Track regulatory submissions, approvals, and renewals.
• Assist in handling queries from regulatory bodies and auditors.
• Maintain regulatory databases and ensure timely updates.

Skills Required:

• Basic knowledge of medical device regulations and documentation
• Understanding of ISO 13485 and regulatory compliance (preferred)
• Strong attention to detail and documentation skills
• Good communication and coordination abilities
• Willingness to learn regulatory processes and global requirements