Company Description Mediplus (India) Limited is a medical device manufacturer specializing in I.V. cannulas and related disposable products that support patient safety and care. In operation since 1995, the company has established a strong reputation in its field and provides key devices such as safety I.V. cannulas, standard I.V. cannulas, three-way stopcocks, and extension tubes. Mediplus focuses on delivering high-quality, durable products through continuous innovation and technological enhancement in its manufacturing processes.

This forward-thinking approach helps strengthen customer trust and maintain high standards in the medical disposables industry.

Role Description The Regulatory Affairs Executive is a full-time, on-site role based in Bahadurgarh. This role involves preparing, reviewing, and maintaining regulatory documentation and dossiers for medical devices to ensure timely submissions and approvals. The executive will monitor and interpret applicable regulatory requirements and standards, and support compliance activities for existing and new products.

Daily tasks include coordinating with cross-functional teams (R&D;, quality, manufacturing, and marketing) to gather technical information, updating internal records and databases, and assisting in audits and inspections.



The role also includes tracking regulatory changes, supporting risk assessments, and contributing to continuous improvement of regulatory processes and documentation practices.

Qualifications

- Robust knowledge of Regulatory Affairs and understanding of regulatory frameworks applicable to medical devices.
- Ability to manage Regulatory Documentation and Dossier Preparation with attention to detail and accuracy.
- Experience working with Regulatory Requirements and ensuring Regulatory Compliance for products and processes.
- Familiarity with national and international medical device regulations (e.g., CDSCO, ISO standards, and other relevant guidelines).
- Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related discipline; advanced qualifications are an advantage.
- Good analytical and problem-solving skills, with the ability to interpret technical data and regulatory guidance.
- Effective written and verbal communication skills for preparing reports, submissions, and cross-functional coordination.
- Proficiency with standard office and documentation tools, and ability to maintain organized regulatory records.
- Prior experience in medical devices or healthcare manufacturing regulatory roles is preferred.

📌 Regulatory Affairs Executive (Bahadurgarh)
🏢 Mediplus India
📍 Bahadurgarh