Jr RA Executive

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 197,000 - 276,000; Full time

Job summary

Arni Medica, a leading medical device manufacturer, invites fresh graduates to join our Regulatory Affairs team in Patancheru, India. This role offers exposure to regulatory regulations, product registrations, and compliance processes.

You will assist in preparing regulatory dossiers, support registrations with CDSCO and global markets, and maintain technical documentation and regulatory records. A detail-oriented mindset and willingness to learn are essential.

Qualifications

• 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.

Responsibilities

• Coordinate with QA, R&D, and production teams for regulatory submissions.
• Maintain regulatory databases and ensure timely updates.
• Assist in handling queries from regulatory bodies and auditors.

Skills

Medical device regulations

ISO 13485 knowledge

Documentation skills

Communication

Willingness to learn

Job description

Patancheru, India

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