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Jr RA Executive
ARNI MEDICA PVT LTD · Shaikpet, Hyderabad, Telangana, India
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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