Regulatory Affairs Executive

This is a full-time on-site role for a Regulatory Affairs Executive in Chennai. The Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, dossier preparation, and other regulatory affairs tasks as assigned.

Maintain Regulatory Files.

Assist in preparing response to Regulatory Authorities' questions with assigned timelines.

Review and create product labels and review promotional materials with applicable regulations and standards.

Conduct Internal Audits

Stay abreast of the response to regulatory authorities questions within the assigned timelines.

Write, analyse and edit technical documents to support country - specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.

Skills

Immediate joiners preferred

Regulatory Documentation and Regulatory Compliance skills

Strong understanding of Regulatory Requirements

Experience with Dossier Preparation

Familiarity with Regulatory Affairs

Strong analytical and problem-solving skills

Excellent written and verbal communication skills

Attention to detail and ability to work independently

Bachelor's or Master's degree in Life Sciences, or related field.

Minimum of 2 years of experience in regulatory affairs in medical devices.

Knowledge of medical device regulations in different countries and regions is a plus.

Familiarity with 21CFR 820, ISO 13485, EU MDR 2017 and Indian Medical Device Rules.

Familiarity with QMS documentation handling.

Strong command over English.