Clinical/Regulatory Affairs Professional

Clinical/Regulatory Affairs Specialist

About the Role:

You will be responsible for supporting clinical and regulatory operations, ensuring compliance with applicable guidelines, preparing documentation for regulatory submissions, and coordinating with authorities for approvals. This is an exciting opportunity to work in the medical device domain and contribute to impactful innovations.

Company Description

PlebC Innovations Private Limited focuses on making affordable and quality healthcare accessible to all, especially in remote areas of India where healthcare infrastructure is lacking. Our team is developing a Tele-Operated Robotic Ultrasound System (TORUS) to provide safe and secure ultrasound services remotely, ensuring timely diagnosis for everyone.

Key Responsibilities:

• Prepare and review regulatory submissions (applications, licenses, approvals).
• Support clinical research activities, trials, and documentation.
• Ensure compliance with CDSCO/ISO/IEC guidelines and other relevant standards.
• Coordinate with regulatory authorities and clinical partners.
• Maintain records, reports, and regulatory documentation.

Requirements:

• Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Biomedical, or related field.
• Knowledge of Indian and international regulatory frameworks (CDSCO, ISO, US FDA/CE preferred).
• Strong writing, documentation, and communication skills.
• Previous experience in clinical research or regulatory affairs (internship/project work is acceptable).

Location:

Interested candidates, please drop mail to omkhar@plebc.com.