ARNI MEDICA PVT LTD
Jr RA Executive
Shaikpet, Hyderabad, Telangana, India
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- Seniority
- Entry level
- Country
- IN
- Work mode
- On-site / unstated
- First seen by hirly
- 27 Sept 2026
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the posting
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
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