Regulatory Assistant

Role & responsibilities

About the Role

We are seeking a detail-oriented and proactive Regulatory Affairs Assistant to support our Quality & Regulatory team in maintaining compliance with ISO 13485:2016 and applicable medical device regulations. In this role you will assist in managing regulatory documentation, supporting submission files, and ensuring audit readiness.

Key Responsibilities

• Documentation & Dossier Preparation: Compile, format, and maintain regulatory submission packages, registration dossiers, and licensing applications.
• Regulatory Submissions: Support the filing of product registrations, renewals, variations, and amendments to health authorities (such as the CDSCO in India or international equivalents like the US FDA).
• Compliance Tracking: Maintain internal tracking systems, databases, and logs to ensure documentation remains current and deadlines are met.
• Cross-Functional Coordination: Collaborate with R&D, Quality Assurance (QA), Quality Control (QC), and manufacturing teams to gather technical data and resolve documentation gaps.
• Query Management: Help draft responses to technical inquiries or additional information requests raised by regulatory agencies or external partners.
• Regulatory Monitoring: Research and monitor updates to regional and global regulatory guidelines, notifying senior staff of changes that impact product lines.

Preferred candidate profile Requirements

Education

Bachelors degree in Life Sciences, Biomedical, Biotechnology Engineering, Chemistry, Pharmacy, or a related technical discipline.

Experience

• 1 to 2 years experience in Regulatory Affairs in a medical device or pharma company

Technical Skills

• Working knowledge of ISO 13485:2016 and QMS documentation
• Familiarity with Medical Device Rules 2017 and the CDSCO online portal (SUGAM)
• Basic understanding of regional regulatory frameworks (e.g., EU MDR, US FDA 21 CFR 820 / QMSR, CDSCO, or local authority guidelines)
• Basic understanding of technical documentation, risk management (ISO 14971) and labelling requirements
• Good command of MS Office (Word, Excel, PowerPoint) and document management practices

Soft Skills

• Strong attention to detail and accuracy
• Good written and verbal communication in English
• Organized, with the ability to manage deadlines and multiple documents
• Ability to work cross-functionally